Intervenciones para el tratamiento de lesiones por atrapamiento de las puntas de los dedos en niños
Resumen
Antecedentes
Las lesiones por atrapamiento de las puntas de los dedos, que incluyen los desgarros de la pulpa y la uña y a menudo una fractura del hueso subyacente, ocurren con frecuencia en los niños, generalmente como resultado de una lesión por aplastamiento. El tratamiento es conservador (limpieza de la herida y apósito de la yema del dedo) o quirúrgico (reparación de laceraciones, reducción y estabilización de fracturas); sin embargo, actualmente no existe consenso con respecto a la modalidad de tratamiento más apropiada.
Objetivos
Evaluar los efectos (beneficiosos y perjudiciales) de las intervenciones quirúrgicas y conservadoras para las lesiones por atrapamiento de las puntas de los dedos en los niños. Se intentó comparar: diferentes métodos de tratamiento conservador; tratamiento quirúrgico versus conservador; diferentes métodos de tratamiento quirúrgico; y diferentes métodos de tratamiento después del tratamiento conservador o quirúrgico inicial.
Métodos de búsqueda
Se hicieron búsquedas en el registro especializado del Grupo Cochrane de Lesiones Óseas, Articulares y Musculares (Cochrane Bone, Joint and Muscle Trauma Group), Registro Cochrane Central de Ensayos Controlados (Cochrane Central Register of Controlled Trials) (The Cochrane Library), MEDLINE, EMBASE, la World Health Organization Clinical Trials Registry Platform y en listas de referencias de artículos hasta el 30 de abril de 2013. No se aplicaron restricciones en cuanto al idioma o el estado de publicación.
Criterios de selección
Ensayos controlados aleatorios (ECA) y cuasialeatorios que compararan intervenciones para tratar las lesiones por atrapamiento de las puntas de los dedos en los niños. Los resultados primarios fueron la función de las puntas de los dedos, el crecimiento de la uña, la deformidad de la uña y eventos adversos como la infección.
Obtención y análisis de los datos
Dos autores de la revisión de forma independiente seleccionaron los estudios para inclusión, evaluaron el riesgo de sesgo de cada estudio incluido y extrajeron los datos. Los desacuerdos se resolvieron mediante discusión.
Resultados principales
Se incluyeron dos ECA que examinaron a 191 niños pequeños e incluyeron 180 en los análisis. Los dos ensayos evaluaron diferentes comparaciones. Ambos ensayos tuvieron alto riesgo de sesgo, en particular por la falta de cegamiento de los participantes y el personal y de la evaluación de resultado. Los ensayos no registraron la función de las puntas de los dedos, el crecimiento de la uña ni la deformidad de la uña. La calidad de la evidencia de los resultados informados se calificó "baja" mediante el enfoque GRADE (es decir, es muy probable que los estudios de investigación adicionales tengan una repercusión importante sobre la confianza en la estimación del efecto y es probable que cambie la estimación).
Un ensayo comparó un ciclo de antibióticos por siete días con ningún antibiótico tras la reparación quirúrgica formal de las lesiones por atrapamiento de las puntas de los dedos. Un niño de cada grupo presentó infección al séptimo día (1/66 grupo de antibiótico versus 1/69 grupo ningún antibiótico; RR 1,05; IC del 95%: 0,07 a 16,37). Ambos participantes con infecciones presentaron una lesión más grave (amputación parcial de las puntas de los dedos).
El otro ensayo comparó el uso de dos apósitos diferentes (red de silicona y gasa de parafina) después del tratamiento quirúrgico o conservador inicial de las lesiones por atrapamiento de las puntas de los dedos. Informó que dos de 20 niños del grupo de silicona versus uno de 25 del grupo de parafina presentaron complicaciones por infección de la herida (CR 2,50; IC del 95%: 0,24 a 25,63) y que uno de 20 niños del grupo de silicona versus dos de 25 del grupo de parafina presentaron necrosis cutánea (CR 0,63; IC del 95%: 0,06 a 6,41). Todas las complicaciones sanaron con el tratamiento conservador. Los resultados para los tiempos medios de cicatrización y el número medio de cambios de apósitos fueron similares entre los grupos, pero no se pudieron excluir los beneficios de los apósitos de silicona o parafina (media de silicona 4,1 semanas versus media de parafina 4,0 semanas; DM 0,10 semanas; IC del 95%: ‐0,61 a 0,81); (media de silicona 4,3 cambios de apósitos versus media de parafina 4,2 cambios de apósitos; DM 0,10; IC del 95%: ‐0,57 a 0,77). El ensayo encontró que fue menos probable que el apósito de silicona se adhiriera a la herida o causara malestar al niño al realizar el cambio de apósito a la semana.
Conclusiones de los autores
Hay falta de evidencia de ECA para informar todas las decisiones de tratamiento clave para el tratamiento de las lesiones por atrapamiento de las puntas de los dedos en los niños.
Debido a que la calidad de la evidencia de un ensayo es baja, no hay evidencia definitiva de que el uso profiláctico de antibióticos después de la reparación quirúrgica no logre reducir el riesgo de infección. Los dos niños que presentaron infección tuvieron heridas más graves.
De igual manera, la evidencia de baja calidad de un ensayo no ha permitido establecer conclusiones firmes con respecto al efecto sobre el tiempo de cicatrización o las complicaciones (infección, necrosis cutánea) a las cuatro semanas de seguimiento entre un apósito de malla de silicona y un apósito de gasa de parafina cuando se aplica después de la cirugía o después de la irrigación simple de la herida; sin embargo, el apósito de malla de silicona puede ser más fácil de retirar en la primera semana.
Se necesitan ECA adicionales en esta área que comparen preferentemente métodos quirúrgicos con métodos conservadores para el tratamiento de las lesiones por atrapamiento de las puntas de los dedos. La evaluación de resultado debe incluir la función de las puntas de los dedos, el crecimiento de la uña y la deformidad de la uña durante un mínimo de tres meses después del tratamiento.
PICO
Resumen en términos sencillos
Tratamientos para las lesiones por atrapamiento de las puntas de los dedos en los niños
Las lesiones por atrapamiento de las puntas de los dedos ocurren con frecuencia en los niños cuando las puntas de los dedos se aprisionan entre la puerta y el marco de la puerta cuando la puerta cierra. Este accidente lesiona la uña del dedo, el tejido circundante y el hueso, todas estructuras importantes en la protección de las puntas de los dedos y para el crecimiento de las uñas. Estas lesiones también son llamadas lesiones de dedos atrapados, lesiones por aplastamiento de las puntas de los dedos o lesiones de puerta batiente.
A veces estas lesiones se tratan sin cirugía ("de forma conservadora") mediante la limpieza y el vendaje de la herida. Alternativamente las lesiones se tratan con cirugía, que habitualmente incluye el uso de un anestésico general, limpieza de la herida y extracción del tejido lesionado, así como dar puntos para reparar cualquier herida en las puntas de los dedos o la uña.
Se buscaron en la bibliografía médica hasta el 30 de abril de 2013 los estudios que comparaban diferentes métodos de tratar las lesiones por atrapamiento de las puntas de los dedos. Esta revisión incluye evidencia de dos estudios que asignaron a los participantes al azar a una de dos condiciones. Los estudios incluyeron a 191 niños, con resultados disponibles para 180 niños. Ambos estudios tuvieron defectos que podrían minar la confiabilidad de los resultados. Puesto que los estudios compararon diferentes métodos, no fue posible combinar los resultados.
Un estudio consideró el uso habitual de antibióticos en los niños con una lesión de las puntas de los dedos reparada quirúrgicamente para prevenir la infección. Debido al escaso número de niños que presentó infección, este estudio no aporta evidencia definitiva del efecto de administrar o diferir el uso de antibióticos. Sólo un niño en cada grupo presentó una infección después de una semana. Ambos niños habían tenido lesiones más graves.
El otro estudio comparó el uso de dos tipos de apósitos diferentes en las lesiones por atrapamiento de las puntas de los dedos. El bajo número de complicaciones fue equivalente en los dos grupos de tratamiento. Debido al escaso número de participantes en el estudio no es posible tener certeza del período de tiempo que las lesiones tardaron en sanar y el número de cambios de apósito fue el mismo en los grupos de tratamiento. Sin embargo, este estudio también encontró que el apósito hecho de silicona causó menos molestias al niño cuando necesitó cambiarse después de la primera semana, probablemente porque se adhirió menos a la herida que el apósito de parafina.
En general no hay evidencia suficiente acerca de cómo tratar mejor las lesiones por atrapamiento de las puntas de los dedos en los niños. Se recomienda realizar estudios de investigación adicionales, especialmente para observar si la cirugía provoca mejores resultados que la limpieza sencilla y colocar un apósito en las heridas. Estos estudios deben evaluar el efecto del tratamiento sobre la función de las puntas de los dedos, el crecimiento de la uña y la deformidad de la uña durante un mínimo de tres meses después del tratamiento.
Authors' conclusions
Background
Description of the condition
Fingertip entrapment injuries are amongst the most common causes for children attending hospital emergency departments. Hand injuries occur at an annual rate of 11.6 per thousand (Shah 2012), of which fingertip injuries comprise between 21% (Fetter‐Zarzeka 2002) and two thirds of all injuries (De Alwis 2006; Inglefield 1995a). The hand is the most frequently injured part of the body after the head in this age group (Ljungberg 2003).
The vast majority of fingertip entrapment injuries occur when the finger is crushed by a closing door (Macgregor 1999). This injury usually occurs in the home (De Alwis 2006; Doraiswamy 2000;Inglefield 1995a), where the door may be closed by the child themselves (13%), an adult (25%) or another child (60%) (Doraiswamy 2000). Frequently, the fingertip is trapped on the hinge side of the door. The middle finger is the most frequently injured (25% to 41% of injuries), followed by the ring finger, little finger, index finger and thumb, respectively (Doraiswamy 2000; Gellman 2009; Inglefield 1995a). Injuries occur in both dominant and non‐dominant hands, with 54% to 66% involving fingers of the right hand (Doraiswamy 2000;Fetter‐Zarzeka 2002). Fingertip injuries are most common in children under five years of age, with this age group comprising 38% of all fingertip injuries compared with 32% in children aged five to 10 years (Doraiswamy 1999).
Fingertip entrapment injuries involve damage to one or more of the following: the finger pulp, nail or bone. The degree of damage to each of these structures depends on the specific injury. The nailbed is damaged in 15% to 26% of injuries (De Alwis 2006; Ljungberg 2003) and a phalangeal (finger bone) fracture occurs in 14% to 50% of cases (Doraiswamy 2000; Gellman 2009; Ljungberg 2003). More severe cases involve avulsion, where tissue or bone is partially or completely pulled away from the body by the force of the injury. If this injury involves complete removal of the fingertip, it is considered an amputation.
The nail serves an important function as part of the fingertip. In addition to cosmetic appearance, the nail gives protection to the fingertip, helps in fine motor skills such as the pincer grip, scratching and picking up small objects, and plays a role in tactile sensation (Gellman 2009;Inglefield 1995a). As a result of a fingertip entrapment injury, the germinal matrix (the region proximal to the nail plate from which it grows) and the sterile matrix (which supports the nail plate from below) can be damaged, affecting future nail growth and leading to dysfunction and disfigurement.
Damage to the nailbed, resulting in altered nail growth, is the major consequence of fingertip entrapment injuries. While damage to the pulp and bone also occur, the future repercussions of these aspects of the injury are less significant. Altered nail growth can result in cosmetic abnormalities, as well as altered sensation and difficulty scratching and pinching.
The tendons of the fingertip are not usually severed (Doraiswamy 2000). Clinically, injuries are frequently only described in terms of the level of injury. The PNB (pulp, nail, bone) classification allows fingertip injuries to be qualitatively assessed and comparisons between different injuries to be drawn, such as the degree of pulp loss, level of nail damage and amount of bone injury (Evans 2000). The PNB classification is summarised in Table 1.
| Pulp | Nail | Bone | |||
| No injury | 0 | No injury | 0 | No injury | 0 |
| Laceration | 1 | Sterile matrix laceration | 1 | Tuft fracture | 1 |
| Crush | 2 | Germinal and sterile matrix laceration | 2 | Comminuted non‐articular fracture | 2 |
| Loss: distal transverse | 3 | Crush | 3 | Articular fracture | 3 |
| Loss: palmar oblique partial | 4 | Proximal nailbed dislocation | 4 | Displaced basal fracture | 4 |
| Loss: dorsal oblique | 5 | Loss: distal third | 5 | Tip exposed | 5 |
| Loss: lateral | 6 | Loss: distal two thirds | 6 | Loss: distal half | 6 |
| Loss: complete | 7 | Loss: lateral | 7 | Loss: subtotal (tendons intact) | 7 |
| ‐‐ | 8 | Loss: complete | 8 | Loss: complete | 8 |
aAdapted from Evans 2000. The PNB classification describes fingertip injuries according to the damage to the three main components of the fingertip. A score is allocated according to the extent or type of injury to each component. Thus PNB 110 = lacerated pulp, sterile matrix laceration to nail, but no injury to bone.
Description of the intervention
Treatment of fingertip entrapment injuries can be either surgical (operative) or conservative (non‐operative). A conservative approach involves irrigation of the injured area with saline and then dressing of the wound with fingertip dressings. Trephination (draining through a small hole) of a haematoma (collection of blood outside the blood vessels) under the nail (subungual haematoma) may be performed to reduce the pain associated with pressure in this area. No form of sedation or anaesthesia is usually required for this process. Treatment usually occurs in a hospital emergency department or in a family doctor's surgery. A variety of dressings may be used, including dressings made from silicone or paraffin gauze. Splints may be used to protect the injured area. Follow‐up of children with these injuries in a clinical setting is rare.
Typically, a surgical approach involves the child undergoing a general anaesthetic, having the injury debrided (the wound cleaned and damaged tissue removed) and then repaired and sutured. This would occur in an operating theatre and is usually performed by a hand surgeon (plastic or orthopaedic). Indications for treatment and variations in technique are often based on practitioner preferences (Gellman 2009). These include whether a nail plate that has remained attached is removed; the material and gauge of sutures used to repair the nailbed and skin; whether antibiotics are given perioperatively; and whether a nail splint (the removed nail or a prosthetic foil) or finger tip splint are used or not. The same variety of dressings are used for surgical treatment as are available for conservative treatment. Follow‐up after repair is usually limited to a single clinic appointment, often between two and 12 weeks postoperatively (West 2011).
As discussed in Description of the condition, fingertip entrapment injuries vary in severity, involving damage to a range of structures in the fingertip (the pulp, nail, and bone). The severity and location of the injury is likely to influence management decisions.
How the intervention might work
One key issue we aimed to cover in this review was whether to treat fingertip entrapment injuries surgically or conservatively. Surgical treatment involves meticulous repair of the fingertip injury in a way that aims to promote rapid wound healing. Surgical repair is thought to result in better nail regeneration and growth, which in turn should result in better functional and cosmetic outcomes in the long term. However, surgical management usually involves general anaesthesia, which is associated with additional risks to the child. These risks are avoided by conservative treatment methods, which also avoid the cost and social impacts of hospital admission and surgical procedures but may result in poorer outcomes.
Why it is important to do this review
Despite the relative frequency of this injury, there is no consensus on the best course of management, with decisions usually based upon the inclination of the individual clinician and not on any local, regional, national or international evidence‐based policy. Both surgical and conservative methods have received support in the literature; some argue that conservative treatment is often acceptable (Inglefield 1995a), while others advocate surgical repair for all but the most minimal injuries (De Alwis 2006). Others argue that trephination of a subungual haematoma and dressing alone has a similar outcome to surgical intervention (Gellman 2009). A study of 283 children aged over six months presenting with such injuries in Glasgow reported that 48% were treated conservatively and 52% were treated surgically, without giving the underlying rationale for treatment decisions (Doraiswamy 1999). The frequent use of surgical repair is likely to contribute to the average cost of £2500 per injury estimated for the UK National Health Service in 2007 (Garvin 2007). Thus, a systematic review of randomised controlled trials was required to ascertain the best course of treatment for this common presentation.
Objectives
To assess the effects (benefits and harms) of surgical and conservative interventions for fingertip entrapment injuries in children.
We aimed to compare:
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Different methods of conservative treatment
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Surgical versus conservative treatment
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Different methods of surgical treatment
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Different methods of management after initial conservative or surgical treatment
Methods
Criteria for considering studies for this review
Types of studies
Randomised controlled trials (RCTs) and quasi‐RCTs (e.g. allocation by alternation or date of birth) evaluating interventions for treating fingertip entrapment injuries in children.
Types of participants
Children with a fingertip entrapment injury. We included RCTs of children less than 12 years old as the mechanism of injury differs in older populations. We adopted a common‐sense approach to exclusion based upon age, wherein we considered each trial in terms of the primary objectives of the review. Thus we would have included RCTs that focused on children but enrolled a small proportion (< 10%) of adults or older children if either: a) separate data had been available for paediatric participants or b) the mechanism of injury was similar to that seen in paediatric populations and the older participants were balanced between comparison groups.
We excluded trials focusing exclusively on the management of fingertip injuries involving amputation or avulsion. However, while the focus of this review was on those injuries that did not result in amputation (see Table 2), we included trials with a proportion of participants with partial or complete amputations where such participants were balanced between the comparison groups and where the mechanism of injury was within the scope of this review.
| Pulp | Nail | Bone | |||
| No injury | 0 | No injury | 0 | No injury | 0 |
| Laceration | 1 | Sterile matrix laceration | 1 | Tuft fracture | 1 |
| Crush | 2 | Germinal and sterile matrix laceration | 2 | Comminuted non‐articular fracture | 2 |
| ‐‐ | Crush | 3 | Articular fracture | 3 | |
| ‐‐ | Proximal nailbed dislocation | 4 | Displaced basal fracture | 4 | |
Types of interventions
We included trials comparing interventions used for treating fingertip entrapment injuries in children. Examples of conservative interventions include simple irrigation and dressing, trephination of a subungual haematoma and dressing, and the use of splints to protect the injured area. Surgical treatment involves debridement and repair, which can be performed in a variety of ways. Factors of interest included the removal of an attached nail, the type and gauge of suture used to repair the different structures of the fingertip, the use of perioperative antibiotics and the use of a splint to protect the injured area. Some interventions, such as the type of dressing, use of antibiotics and the type of protective splint, apply to both conservative and surgical treatments.
Types of outcome measures
The measurement of both subjective and objective outcomes is difficult in young children. Therefore we anticipated that outcomes would usually be reported by parents.
Primary outcomes
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Fingertip function (dexterity; likely to be measured subjectively based upon parents' comments)
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Nail growth (likely to be measured in terms of growth or time, or dichotomously, e.g. nail present or absent at follow‐up)
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Nail deformity (likely to be measured subjectively, or using a grading system unique to each trial, as no universally‐adopted system currently exists)
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Adverse events (e.g. wound infection, distal necrosis of fingertip, hypertrophic scarring, growth arrest)
Secondary outcomes
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Child or parent satisfaction, or both (e.g. with the intervention; with appearance)
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Pain and sensation (these are unlikely to be reported because of the age of the typical patient; however, patient distress may be recorded at the time of the intervention)
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Time to healing of injury (likely to be reported subjectively)
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Requirement for secondary procedures to improve function or appearance (likely to be surgical interventions performed after the injury is fully healed).
Search methods for identification of studies
Electronic searches
We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (April 2013), the Cochrane Central Register of Controlled Trials (The Cochrane Library, 2013 Issue 4), MEDLINE (1946 to April Week 3 2013), and EMBASE (1980 to 2013 Week 17). We also searched the WHO International Clinical Trials Registry Platform (to April 2013) for ongoing trials. We did not apply any restrictions based on language or publication status.
The search strategies for The Cochrane Library, MEDLINE, EMBASE and the WHO International Clinical Trials Registry Platform are listed in Appendix 1. The MEDLINE strategy combined subject‐specific search terms with the sensitivity‐maximising version of the Cochrane Highly Sensitive Search Strategy for identifying RCTs in MEDLINE (Lefebvre 2011).
Searching other resources
We searched reference lists of relevant articles.
Data collection and analysis
Selection of studies
Using a study eligibility form, both authors independently screened all identified studies for possible inclusion in the review. We then compared individual lists of included trials and resolved any disagreements through discussion. We contacted trial authors of two studies (Alpern 2005; Strauss 2008) to inform trial selection.
Data extraction and management
Both authors extracted data independently using a form piloted on several selected trials beforehand and resolved disagreements through discussion. One author (RC) entered the data into Review Manager (RevMan) software.
Assessment of risk of bias in included studies
Both authors assessed the risk of bias independently using The Cochrane Collaboration's 'Risk of bias' tool (Higgins 2011). Using this tool we assessed selection bias due to inadequate sequence generation or allocation concealment; performance bias due to lack of blinding of participants and personnel; detection bias due to lack of blinding of outcome assessment; attrition bias resulting from incomplete outcome data; reporting bias in the form of selective reporting; and 'other bias'.
Measures of treatment effect
For each trial, we calculated the risk ratio (RR) and 95% confidence intervals (CIs) for dichotomous outcomes, and mean differences (MD) and 95% CIs for continuous outcomes. Where continuous data were measured using different scales, we calculated the standardised mean difference (SMD) where such data were pooled.
Unit of analysis issues
Most injuries were expected to involve single fingers. However, we anticipated that unit of analysis could have been an issue if trials presented data for individual fingers rather than for individual participants (unit of randomisation) where some participants had more than one injured finger. If such an issue arose and appropriate corrections had not been made, we planned to present the data for such trials where the disparity between the units of analysis and randomisation was small (and thus the proportion of participants with multiple finger involvement was very small). However, this was not relevant for any trials included in the review. If data had been pooled, it would have been necessary to perform a sensitivity analysis to examine the effects of excluding incorrectly reported trials from the analysis.
Dealing with missing data
Where data were missing from published reports, we planned to contact authors via email. Where possible, we performed intention‐to‐treat analysis.
Assessment of heterogeneity
We planned to assess statistical heterogeneity using the visual inspection of forest plots in Review Manager (RevMan) combined with the Chi² test (with statistical significance set at P < 0.10), and the I² statistic (with an I² between 50% to 90% likely to represent substantial heterogeneity and 75% to 100%, representing considerable (very substantial) heterogeneity) (section 9.5.2; Higgins 2011). However, as none of the included trials compared similar interventions, we did not conduct statistical assessment of heterogeneity.
Assessment of reporting biases
If appropriate in a future update, we will explore publication bias using a funnel plot if there are at least 10 trials reporting the same outcome.
Data synthesis
If appropriate in a future update, we plan to pool results from trials with comparable participant characteristics and interventions using the fixed‐effect model. We will consider using the random‐effects model if there is significant or substantial unexplained heterogeneity, or both.
Subgroup analysis and investigation of heterogeneity
If sufficient data are available in a future update, we will investigate heterogeneity by subgroup analyses based on the aspects listed below.
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Anatomical level and classification of injury (in particular, different involvement of pulp, nail and bone components).
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Length of follow‐up. We will consider up to three months as short term (i.e. relating to a single nail growth cycle) and over three months as long term.
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Age of the child. We will compare the age group that accounts for the majority of these injuries (0 to 4 years) with the older age groups (5 to 8 years, and 9 to 12 years). The mechanism of injury is likely to be different in older children.
We will use the test for subgroup differences available in Review Manager (RevMan) to determine if the results for subgroups are statistically significantly different.
Sensitivity analysis
If appropriate in a future update, we will undertake sensitivity analysis to determine the impact of bias within individual trials on the meta‐analysis. The effect of removing trials with a high risk of bias will be analysed, with inadequate allocation concealment leading to selection bias being of primary interest. If, on visual inspection of an analysis, a trial appears to be the source of substantial heterogeneity, we will conduct a sensitivity analysis to assess the effect of excluding this trial from the analysis.
Assessing the quality of the evidence
We used the GRADE approach to assess the quality of evidence related to each of the primary outcomes listed in the Types of outcome measures (Higgins 2011). If sufficient data are available in a future update, we will present the main results of this review in 'Summary of findings' tables.
Results
Description of studies
Results of the search
The search was completed in April 2013. We screened a total of 363 records from the following databases: Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (17 records); Cochrane Central Register of Controlled Trials (90), MEDLINE (148), EMBASE (108) and the WHO International Clinical Trials Registry Platform (9). We also identified eight potentially eligible studies from other sources (reference lists of potentially eligible studies).
The search resulted in the identification of 33 potentially eligible studies, for each of which full reports were obtained (35 reports). Upon trial selection, we included two trials: Altergott 2008 (published in two reports) and O'Donovan 1999; and excluded 30 studies (listed in the Characteristics of excluded studies). One unpublished trial is awaiting classification (Alpern 2005). We did not identify any trials as ongoing. Figure 1 is a flow diagram summarising the trial selection process.
Study flow diagram
Overall, we included two trials, excluded 30 studies, identified one trial awaiting classification and no ongoing studies.
Included studies
The two included trials were published as full reports in journals, one in 1999 and one in 2008. We have summarised key information about the trials below and provided fuller details of methods, participants, interventions and outcomes for the individual trials in the Characteristics of included studies table.
Design
The two trials (Altergott 2008; O'Donovan 1999) were described as randomised; however, O'Donovan 1999 did not describe the method of randomisation. Participants and personnel were not blinded in either of the trials.
Sample size
The two trials had a total sample size of 191: Altergott 2008 included 146 children and O'Donovan 1999 included 45 children.
Setting
Both were single centre trials. Altergott 2008, which was conducted in the United States of America, recruited participants from September 2000 to July 2004. O'Donovan 1999, which was conducted in Ireland, recruited over an unspecified four‐month period.
Participants
Both trials had paediatric populations. In Altergott 2008, the mean age was 3.2 years in the antibiotic group and 3.0 years in the no antibiotic group. The mean age in both intervention and control groups in O'Donovan 1999 was 4.6 years. The youngest participant in each trial was six months of age.
Altergott 2008 included fingertip injuries distal to the distal interphalangeal joint requiring surgical repair. O'Donovan 1999 included fingertip injuries involving the pulp, nail complex or distal phalanx. The majority of children in both trials had injuries that did not involve amputation of the fingertip, in keeping with the scope of this review (see Table 2). However, both trials included a proportion of participants that had undergone a partial or total amputation; in both cases these participants were balanced between the intervention and control groups. We have summarised inclusion and exclusion criteria in the Characteristics of included studies table.
Interventions
Each trial compared a different intervention. Altergott 2008 compared prophylactic antibiotics with no antibiotics following surgical repair of fingertip injuries. O'Donovan 1999 compared a silicone net dressing with paraffin gauze following either surgical (31 participants) or initial conservative (14 participants) management of fingertip injuries.
Outcomes
Follow‐up was for seven days in Altergott 2008 and four weeks in O'Donovan 1999. Neither trial reported on this review's primary outcomes of fingertip function, nail growth and nail deformity. Both trials recorded infection rate as an outcome: this was the primary outcome in Altergott 2008, while O'Donovan 1999 recorded it as a complication. A secondary outcome in Altergott 2008 was antibiotic compliance within the prophylactic antibiotic group. O'Donovan 1999 measured the number of dressing changes required until the wound healed, as well as perceived level of patient stress, wound adhesion and the rate of complications.
Excluded studies
We have listed brief details and reasons for the exclusion of 30 studies in the Characteristics of excluded studies table. We excluded 16 studies because they did not make a comparison between two or more interventions. Four studies were excluded because they were conducted retrospectively. We excluded nine studies because they were either not conducted in paediatric participants or did not focus on the injuries of interest to this review (Table 2). Also, we excluded one trial because although it was conducted prospectively it was not randomised or quasi‐randomised.
Studies awaiting classification
Alpern 2005 awaits classification. This trial aimed to compare different types of local anaesthetic for fingertip injuries in children. It was registered in 2005 with clinicaltrials.gov and was seemingly completed in 2007; however, we did not find any published report of its results. We contacted the author directly and they indicated that the trial manuscript is currently under revision for publication. We summarised details of the trial in the Characteristics of studies awaiting classification table.
Risk of bias in included studies
We summarised the risk of bias on seven items for each of the included trials in Figure 2 and described them in the 'Risk of bias' tables in the Characteristics of included studies section. In Figure 2, a (+) judgement indicates that we considered there to be low risk of bias for the specific item, while a (‐) judgement indicates a high risk of bias. An unclear (?) verdict indicates that we were unable to determine the impact of the specific bias item on the trial.
Risk of bias summary: review authors' judgements about each risk of bias item for each included trial. See each trial's individual Risk of Bias table for explanation.
Allocation
Altergott 2008 had a low risk of selection bias relating to sequence generation and allocation concealment. O'Donovan 1999 was at unclear risk of bias as the allocation method was described as randomised, but no further details were provided.
Blinding
Participants and personnel were not blinded at any point in either of the studies, nor were outcome assessors. Both studies were therefore judged to be at high risk of performance bias and detection bias.
Incomplete outcome data
In Altergott 2008, 7% of participants in the intervention group and 8% of participants in the control group were lost to follow‐up. Although the trial reported the reasons for attrition, the trial authors did not report the distribution of these reasons between the groups. It was unclear what impact attrition bias had upon the trial's findings. O'Donovan 1999 followed all participants up to the conclusion of the trial, and so the trial was at low risk of attrition bias.
Selective reporting
A trial protocol for Altergott 2008 was available through the WHO International Clinical Trials Registry Platform. The outcomes reported matched those from the protocol, and the risk of reporting bias was judged to be low. O'Donovan 1999 reported all outcomes outlined in the methods section; however, no trial protocol was available for comparison and it was unclear if the trial was at risk of reporting bias.
Other potential sources of bias
Injury severity
In Altergott 2008, participant enrolment was at the discretion of the clinical team (where inclusion criteria applied). The trial authors considered that this approach had the potential to skew the participant population towards less severe injuries, with more complicated injuries not being enrolled in the trial. We agreed with this assessment.
Conversely, in O'Donovan 1999 only those participants who were referred to the plastic surgery department could potentially be enrolled in the trial. As more minor injuries may have been managed in the emergency department without referral, it is possible that this method resulted in a participant population skewed towards more severe injuries.
However, provided there was allocation concealment, skewing of the patient population in terms of injury severity in either Altergott 2008 or O'Donovan 1999 is unlikely to have impacted the internal validity of either trial. Rather, it would limit the applicability of the results each trial reports when a broader patient population with injuries ranging in severity is considered.
Length of follow‐up
Altergott 2008 followed up participants for seven days and assessed them for the presence of infection at this time. However, the trial authors noted that after the trial conclusion a further four participants were found to have an infection on chart review. As these infections occurred outside the time period of the trial, the trial authors did not include them in the trial's results. This suggests a potential bias from an inappropriately short follow‐up period; it is unclear what impact on the results a longer follow‐up would have had.
In contrast to Altergott 2008, where patients were discharged with a scheduled follow‐up visit at 48 hours and final follow‐up at seven days, participants in O'Donovan 1999 had weekly dressing changes performed in dressing clinics for four weeks. Such a disparity in follow‐up length may reflect the lack of standardisation in general clinical practice.
Effects of interventions
We listed the outcomes reported in the included trials in the Characteristics of included studies section. Also, we have presented outcome data reported at final follow‐up for each trial in Data and analyses. Pooling of data was not undertaken as the two included trials reported different comparisons. Neither of these measured the primary outcomes of fingertip function (either subjectively or objectively), nail growth or nail deformity. Neither trial assessed the secondary outcomes of participant or parent satisfaction, or fingertip sensation.
Different methods of conservative treatment
O'Donovan 1999 compared two types of finger dressings and included 14 participants (31%) who were treated conservatively. However, separate data for these participants were not available and therefore we could not directly compare the different dressings in a population receiving only conservative treatment.
Surgical versus conservative treatment
No trials compared surgical with conservative treatment.
Different methods of surgical treatment
No trials directly compared different methods of surgical treatment.
Different methods of management after initial conservative or surgical treatment
Prophylactic antibiotics
In Altergott 2008, the use of prophylactic antibiotics was compared with no prophylactic antibiotics after formal surgical repair in 146 children. Altergott 2008 found no difference in presence of infection at the seventh postoperative day as determined by review via telephone and confirmed by visual examination in person (1/66 antibiotic group versus 1/69 no antibiotic group; RR 1.05, 95% CI 0.07 to 16.37; see Analysis 1.1). The authors noted that each of the two injuries that became infected, both partial amputations, had been repaired with a larger than average number of sutures (infected cases had eight and nine sutures respectively; in non‐infected cases the mean number of sutures was 4.9, SD 2.0). Both participants made a full recovery after treatment for their infection. In terms of antibiotic compliance, 86.2% (59/66) of the children in the antibiotic group had consumed at least 75% of the prescribed doses at the day seven telephone interview.
Silicone dressings versus paraffin dressings
O'Donovan 1999 compared silicone net dressings with paraffin gauze dressings after either surgical management (debridement only, nailbed repair, composite grafts, or local (V‐Y) flaps) or initial conservative management (simple wound irrigation) of fingertip entrapment injuries.
There were no significant differences between the two dressings in the reported complications of wound infection (2/20 silicone group versus 1/25 paraffin group; RR 2.50, 95% CI 0.24 to 25.63; see Analysis 2.1) or skin necrosis (1/20 silicone group versus 2/25 paraffin group; RR 0.63, 95% CI 0.06 to 6.41; see Analysis 2.1). All complications healed with conservative management; however, one patient with an amputated fingertip in the paraffin group had an "active cellulitis" that required hospital readmission.
O'Donovan 1999 found no differences between groups in either the mean healing times (silicone mean 4.1 weeks versus paraffin mean 4.0 weeks; MD 0.10 weeks, 95% CI ‐0.61 to 0.81; see Analysis 2.2) or the mean number of dressing changes (silicone mean 4.3 versus paraffin mean 4.2; MD 0.10, 95% CI ‐0.57 to 0.77; see Analysis 2.3).
When the dressings were compared in terms of level of distress experienced by the child during a dressing change, a low level of perceived stress (defined as "happy" or only "mildly upset"), was significantly more common in the silicone dressing group at the week one dressing change (19/20 silicone group versus 9/25 paraffin group; RR 2.64, 95% CI 1.55 to 4.49; see Analysis 2.4). At the week two dressing change, the silicone dressing was again favoured; however, this difference was not statistically significant. No difference was found at the week three or week four dressing changes. A similar pattern favouring the silicone group was reported for observed adhesion of the dressing to the wound (see Analysis 2.5). Dressings were significantly more likely to have "slipped off" or were "gently teased off" in the silicone dressing group than in the paraffin group at the week one dressing change (18/20 silicone versus 12/25 paraffin; RR 1.88, 95% CI 1.22 to 2.89). At the week two dressing change, the silicone dressing was again favoured in terms of adhesion; however, this difference was not statistically significant. No difference was found at the week three or week four dressing changes; just one paraffin dressing had to be soaked for removal on each occasion.
Discussion
Summary of main results
This review, which covers all surgical and conservative interventions for treating fingertip entrapment injuries in children, includes two single‐centre trials that tested different comparisons and reported results for a total of 180 young children. Each of the trials focused on outcomes measurable over a short time frame rather than primary outcomes of this review such as fingertip function, nail growth and nail deformity, which tend to be measured over longer periods of time.
One trial (Altergott 2008) compared a seven‐day course of prophylactic antibiotics with no antibiotics after surgical repair. One child in each group had an infection at day seven. Both infections were in children who had a partial amputation of their fingertip.
The other trial (O'Donovan 1999) compared silicone versus paraffin dressings after initial conservative or surgical management. The trial found similar results in the two groups in terms of complications (infection, skin necrosis) at four‐week follow‐up, and in the mean injury healing times and mean number of dressing changes. However, it found that at the week one dressing change the silicone net dressing adhered less to the wound and caused less distress for the child.
No trials compared surgical versus conservative management or different methods of surgical management. Aspects of surgical interventions that were of particular interest to this review such as removal of an attached nail, the type and gauge of suture used and the use of a splint to protect the injured area were not evaluated in either of the included trials.
Overall completeness and applicability of evidence
The available evidence from RCTs is very limited and comes from two small single‐centre non‐blinded trials that did not report on our primary outcomes of fingertip function, nail growth or nail deformity. Altergott 2008 reported on wound infection at the day seven follow‐up. This time period was too short, as illustrated by the subsequent finding of later infections from via chart review.
The age distribution in both trials was characteristic of the usual population with these injuries. While the intended focus of this review was those injuries that did not result in amputation, as described in the Types of participants section both trials included a minority of participants with partial or complete amputations. This potentially limits the applicability of the evidence when considering less severe injuries, which were the intended injury population of this review. As discussed under Other potential sources of bias, the different treatment settings and enrolment methods in the two trials may have skewed the populations in terms of injury severity.
Quality of the evidence
We used the GRADE approach to assess the quality of evidence relating to each outcome for which results were available (Higgins 2011). There was a notable absence of evidence for our key primary outcomes of fingertip function, nail growth and nail deformity. We downgraded the quality of evidence for each reported outcome by two levels to 'low quality'; once for limitations in design and implementation (given that neither trial was blinded, introducing performance and detection bias), and once for imprecision (given that results for each outcome were based on a small number of events in a single trial). This indicates that further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Potential biases in the review process
We undertook systematic processes as outlined in order to minimise the potential for bias in this review. While our literature search was extensive, it is possible that we did not identify some RCTs particularly those only reported in abstract form, communicated at conferences or published in non‐English language journals. Due to our inclusion criteria we may have overlooked mixed‐population trials examining interventions in fingertip entrapment injuries where a number of paediatric participants were included and analysed within a larger adult population. However, it is almost certain that we have not overlooked paediatric trials that would provide definitive evidence for application to routine clinical practice.
Some adjustment to the inclusion criteria was required to accommodate the populations in the included trials. This review aimed to focus on injuries that did not result in amputation. However, while we excluded trials exclusively examining the management of fingertip amputation, both included trials had a proportion of injuries severe enough to cause amputation. We included these trials because amputated cases were in the minority, were evenly distributed across the comparison groups, and the mechanism of injury was within the scope of this review. However, the inclusion of these trials effectively shifts the review towards more severe injuries. Secondly, O'Donovan 1999 included both surgically and conservatively‐treated participants. Thus we adjusted the scope of our fourth comparison to "different methods of management after initial conservative or surgical treatment" to reflect this.
Agreements and disagreements with other studies or reviews
We did not identify any other systematic reviews on fingertip injuries in children during our literature search.
Study flow diagram
Risk of bias summary: review authors' judgements about each risk of bias item for each included trial. See each trial's individual Risk of Bias table for explanation.
Comparison 1 Prophylactic antibiotics versus no antibiotics following surgical repair, Outcome 1 Infection.
Comparison 2 Silicone net dressing versus paraffin gauze following surgical or conservative management, Outcome 1 Complications.
Comparison 2 Silicone net dressing versus paraffin gauze following surgical or conservative management, Outcome 2 Healing time in weeks.
Comparison 2 Silicone net dressing versus paraffin gauze following surgical or conservative management, Outcome 3 Number of dressing changes.
Comparison 2 Silicone net dressing versus paraffin gauze following surgical or conservative management, Outcome 4 Low level of stress experienced by child during dressing change.
Comparison 2 Silicone net dressing versus paraffin gauze following surgical or conservative management, Outcome 5 Low degree of wound adhesion during dressing change.
| Pulp | Nail | Bone | |||
| No injury | 0 | No injury | 0 | No injury | 0 |
| Laceration | 1 | Sterile matrix laceration | 1 | Tuft fracture | 1 |
| Crush | 2 | Germinal and sterile matrix laceration | 2 | Comminuted non‐articular fracture | 2 |
| Loss: distal transverse | 3 | Crush | 3 | Articular fracture | 3 |
| Loss: palmar oblique partial | 4 | Proximal nailbed dislocation | 4 | Displaced basal fracture | 4 |
| Loss: dorsal oblique | 5 | Loss: distal third | 5 | Tip exposed | 5 |
| Loss: lateral | 6 | Loss: distal two thirds | 6 | Loss: distal half | 6 |
| Loss: complete | 7 | Loss: lateral | 7 | Loss: subtotal (tendons intact) | 7 |
| ‐‐ | 8 | Loss: complete | 8 | Loss: complete | 8 |
| aAdapted from Evans 2000. The PNB classification describes fingertip injuries according to the damage to the three main components of the fingertip. A score is allocated according to the extent or type of injury to each component. Thus PNB 110 = lacerated pulp, sterile matrix laceration to nail, but no injury to bone. | |||||
| Pulp | Nail | Bone | |||
| No injury | 0 | No injury | 0 | No injury | 0 |
| Laceration | 1 | Sterile matrix laceration | 1 | Tuft fracture | 1 |
| Crush | 2 | Germinal and sterile matrix laceration | 2 | Comminuted non‐articular fracture | 2 |
| ‐‐ | Crush | 3 | Articular fracture | 3 | |
| ‐‐ | Proximal nailbed dislocation | 4 | Displaced basal fracture | 4 | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Infection Show forest plot | 1 | Risk Ratio (IV, Fixed, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Complications Show forest plot | 1 | Risk Ratio (IV, Fixed, 95% CI) | Totals not selected | |
| 1.1 Infection | 1 | Risk Ratio (IV, Fixed, 95% CI) | 0.0 [0.0, 0.0] | |
| 1.2 Skin necrosis | 1 | Risk Ratio (IV, Fixed, 95% CI) | 0.0 [0.0, 0.0] | |
| 2 Healing time in weeks Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 3 Number of dressing changes Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 4 Low level of stress experienced by child during dressing change Show forest plot | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 4.1 Week 1 | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.0 [0.0, 0.0] | |
| 4.2 Week 2 | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.0 [0.0, 0.0] | |
| 4.3 Week 3 | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.0 [0.0, 0.0] | |
| 4.4 Week 4 | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.0 [0.0, 0.0] | |
| 5 Low degree of wound adhesion during dressing change Show forest plot | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| 5.1 Week 1 | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.0 [0.0, 0.0] | |
| 5.2 Week 2 | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.0 [0.0, 0.0] | |
| 5.3 Week 3 | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.0 [0.0, 0.0] | |
| 5.4 Week 4 | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.0 [0.0, 0.0] | |
