Saline irrigation for the management of skin extravasation injury in neonates

P N Gopalakrishnan; Nitin Goel; Sujoy Banerjee

doi:10.1002/14651858.CD008404.pub3

Saline irrigation for the management of skin extravasation injury in neonates

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Referencias

References to studies excluded from this review

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otras referencias

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Characteristics of studies

Characteristics of excluded studies [ordered by study ID]

Study	Reason for exclusion
Casanova 2001	Case series
Chen Y Y 1996	Case report
Chowdhury 2004	Retrospective review of 31 cases
Davies 1994	Case report
Gault 1993	Retrospective review of 96 cases
Harris 2001	Retrospective review
Kostogloudis 2015	Case report
Kuensting 2010	Case report
Martin 1994	Case report
Siu 2007	Case report

All 10 studies are either case reports or case series. Time to intervention from extravasation is highly variable. In all 10 studies, participants were neonates only. All 10 studies reported their outcomes as complete wound healing and no functional and cosmetic disability.

Figure 1

Study flow diagram: review update.

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Summary of findings for the main comparison. Saline irrigation with or without prior infiltration of hyaluronidase vs standard wound care for management of extravasation injury in neonates

Saline irrigation with or without prior infiltration of hyaluronidase vs standard wound care for management of extravasation injury in neonates
Patient or population: neonates requiring management of extravasation injury Setting: neonatal intensive care units Intervention: saline irrigation with or without prior infiltration of hyaluronidase Comparison: standard wound care
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with standard wound care	Risk with saline irrigation with or without prior infiltration of hyaluronidase
Complete wound healing after saline irrigation with or without prior hyaluronidase infiltration (wound healing): clinical assessment	Study population		Not estimable	237 (10 observational studies)	⊕⊝⊝⊝ Very low	Pooled data for 237 neonates from 10 case report studies who underwent saline irrigation. Three neonates received further surgical intervention. For 234 neonates, complete wound healing was reported
	0 per 1000	0 per 1000 (0 to 0)
*The risk in the intervention group (and its 95% confidence interval) is based on assumed risk in the comparison group and relative effect of the intervention (and its 95% CI) CI: confidence interval; OR: odds ratio; RR: risk ratio
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to the estimate of effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of effect but may be substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
All 10 studies analysed in GRADE pro GDT are case reports, and the intervention methods mentioned are highly variable. In view of this, "relative effect (95% CI)" and "absolute effect (95% CI)" were not derived.

Summary of findings for the main comparison. Saline irrigation with or without prior infiltration of hyaluronidase vs standard wound care for management of extravasation injury in neonates

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Table 1. Summary of excluded studies ‐ study design, population, intervention, and outcome

Study	Type of study	Number of neonates	Extravasation	Intervention	Outcome
Casanova 2001	Case series	14 neonates	Dopamine ‐ 9 Caffeine ‐ 2 Calcium ‐ 2 Beta blocker ‐ 1	Hyaluronidase infiltration and aspiration ‐ 12 Saline irrigation and aspiration ‐ 1 Hyaluronidase infiltration alone ‐ 1	3 cases developed skin necrosis but healed spontaneously
Chen Y Y 1996	Case report	1 neonate	Total parenteral nutrition (TPN)	Infiltration with hyaluronidase with saline irrigation	Healing in 3 days
Chowdhury 2004	Retrospective review of 31 cases	31 neonates had 36 extravasations	TPN ‐ 13 Medications ‐ 10 Blood products ‐ 6 Crystalloids ‐ 5 Contrast ‐ 2	Hyaluronidase infiltration and saline irrigation used for 24 extravasation injuries	No surgical graft required
Davies 1994	Case report	2 preterm neonate less than 29 weeks gestation	TPN	Hyaluronidase infiltration and saline irrigation	Minimal or no scarring, no functional sequelae
Gault 1993	Retrospective review of 96 cases	Total 96 cases referred to a tertiary plastic surgical unit (age range ‐ preterm neonate to 72 years ‐ exact distribution not mentioned) 44 early referrals, i.e. within 24 hours 52 late referral, i.e. after 24 hours	TPN Inotrope Ca KCl Bicarbonate Dextrose: 10%‐20% Chemotherapeutics Contrast Antibiotics (exact numbers not mentioned)	Early referral group: 44 (saline irrigation alone ‐ 37, liposuction and saline irrigation ‐ 6, liposuction alone ‐ 1) Late referral group: wound and surgical management	Early referral group: 39 (88.5%) no soft tissue damage, 5 (11.5%) minor skin blistering Late referral group: 8 (15%) healed without tissue necrosis, 17 (33%) minor skin sloughing, 27 (52%) extensive damage to tissues ‐ 3 amputations
Harris 2001	Retrospective review	56 neonates	TPN Inotrope Calcium Potassium chloride Sodium bicarbonate High concentration of dextrose (exact numbers not mentioned)	Saline irrigation alone	No skin loss. None required reconstructive surgery
Kostogloudis 2015	Case report	34 neonates	TPN ‐ 28 10% dextrose ‐ 4 Second‐generation cephalosporin ‐ 2	Saline irrigation followed by topical application of paraffin‐impregnated gauze and povidone‐iodine‐soaked gauze dressing	In 21 infants, no signs of soft tissue damage by 24 hours of treatment Minor findings still present for a few days in 7 patents after treatment Ischaemic signs present in 6 patients subsided within 25 days
Kuensting 2010	Case report	1 neonate	Antibiotics	Infiltration with recombinant human hyaluronidase (rHuPH20)	Wound healed completely by 8 days
Martin 1994	Case report	1 neonate	Dobutamine, adrenaline, 8.4% sodium bicarbonate, 10% calcium gluconate	Infiltration of hyaluronidase followed by liposuction and saline irrigation	No signs of soft tissue damage at 2 weeks
Siu 2007	Case report	1 neonate	TPN	Hyaluronidase infiltration and saline irrigation	Healed fully by 5 days

Table 1. Summary of excluded studies ‐ study design, population, intervention, and outcome

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Table 2. Summary of excluded studies ‐ stage of extravasation and intervention and its outcome

Study	Stage of extravasation	Intervention	Outcome	Reason for exclusion
Casanova 2001	Skin necrosis (stage 3): n = 3 Swelling, oedema, discolouration (stage 1‐2): n = 11	Hyaluronidase and aspiration ‐ 12 cases Hyaluronidase infiltration alone ‐ 1 Saline irrigation and aspiration ‐ 1 Treatment allocation not specified by stage of injury	No sequelae	Neither a randomised nor a quasi‐randomised study
Chen Y Y 1996	Swelling, erythema, and induration (stage 3): n = 1	Hyaluronidase and saline irrigation	No sequelae	Neither a randomised nor a quasi‐randomised study
Chowdhury 2004	Erythema and oedema (stage 1‐2): n = 12 Skin necrosis (stage 3): n = 24	Stage 1‐2 ‐ standard wound management Stage 3 ‐ hyaluronidase and saline irrigation	No sequelae No sequelae	Neither a randomised nor a quasi‐randomised study
Davies 1994	Skin necrosis (stage 3): n = 2	Hyaluronidase and saline irrigation	Minimal scarring, no sequelae	Neither a randomised nor a quasi‐randomised study
Gault 1993	Skin necrosis (stage 3): Early referral: n = 44 Delayed referral (stage 3‐4): n = 52	Stage 3: Saline irrigation alone: n = 37 Liposuction and saline irrigation: n = 6 Liposuction alone: n = 1 Stage 3‐4: Wound debridement and surgical flap	No sequelae 8 (15%) healed without tissue necrosis, 17 (33%) minor skin sloughing, 27 (52%) extensive damage to tissues ‐ 3 amputations	Neither a randomised nor a quasi‐randomised study
Harris 2001	Exact stage of extravasation injury not specified: n = 56	Saline irrigation	No sequelae	Neither a randomised nor a quasi‐randomised study
Kostogloudis 2015	Stage 3 and stage 4 extravasation	Saline irrigation within 30 minutes of extravasation injury	None of the wounds needed secondary skin coverage procedures	Neither a randomised nor a quasi‐randomised study
Kuensting 2010	Discolouration, oedema, cool, pulses not palpable (stage 4): n = 1	Infiltration with recombinant human hyaluronidase (rHuPH20)	No sequelae	Neither a randomised nor a quasi‐randomised study
Martin 1994	Oedema, pallor, cold, and no capillary filling	Infiltration with hyaluronidase, liposuction, and saline irrigation	No sequelae	Neither a randomised nor a quasi‐randomised study
Siu 2007	Skin necrosis (stage 3): n = 1	Hyaluronidase and saline irrigation	No sequelae	Neither a randomised nor a quasi‐randomised study

Table 2. Summary of excluded studies ‐ stage of extravasation and intervention and its outcome

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Referencias

References to studies excluded from this review

Casanova 2001 {published data only}

Chen Y Y 1996 {published data only}

Chowdhury 2004 {published data only}

Davies 1994 {published data only}

Gault 1993 {published data only}

Harris 2001 {published data only}

Kostogloudis 2015 {published data only}

Kuensting 2010 {published data only}

Martin 1994 {published data only}

Siu 2007 {published data only}

Additional references

Brown 1979

Bruera 1999

Cartlidge 1990

Chandanvasu 1986

Cho 2007

Davidson 1985

Falcone 1989

Flemmer 1993

Fox 1998

Friedman 1998

Fullilove 1997

Goutos 2014

GRADEpro GDT [Computer program]

Hadaway 2007

Higgins 2011

Irving 1999

Irving 2001

Jaworski 1950

Kumar 2001

Lee 2013

McCullen 2006

Millam 1988

Moss 2001

Onesti 2012

Patnaik 2004

PPAG 2005

Ramasethu 2004

Restieaux 2013

Reynolds 2007

Reynolds 2014

Sawatzky‐Dickson 2006

Schünemann 2013

Thomas 1997

Tong 2007

Valente 2001

Wilkins 2004

Characteristics of studies

Characteristics of excluded studies [ordered by study ID]

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