Wound cleansing for pressure ulcers
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To assess the effects of wound cleansing solutions and techniques on the healing rates of pressure ulcers.
Background
Pressure ulcers (also known as pressure sores, bed sores and decubitus ulcers) are localised areas of tissue damage caused by excess pressure, shearing or friction forces, commonly occurring in individuals, who due to age, illness or immobility cannot tolerate the effect of these forces (Robertson 1990). One European study found that approximately 18% of hospital patients had a pressure ulcer (EPUAP 2002). An Irish study confirmed the extent of the problem when, following assessment of 297 adult in patients, a prevalence of 12.5% was observed (Moore 2000). Reported pressure ulcer incidence rates range from 2.2% ‐ 66% in the UK and 0% ‐ 65.6% in the USA and Canada (Kaltenthaler 2001). These figures are influenced by the location and condition of the patient group (hospital vs. community setting, general hospital patients vs. those with fractured neck of femur) (Richardson 1981; Versluysen 1986; Hanson 1993; Bridel 1996).
The presence of a pressure ulcer impacts on the individual in many ways (Clark 1994). For example, pressure ulcers are painful (Szor 1997) and malodorous, especially when there is a large amount of devitalised tissue amalgamated with the presence of anaerobic bacteria in the wound bed (Stotts 2001). Combined with this, pressure ulcers can exude profusely, particularly during the early inflammatory phase (Iocono 1998), thereby necessitating frequent dressing changes (Rolstad 2000). It has been noted that the issues of concern to patients associated with their pressure ulcers were pain, exudate, body image and worry about healing (Fox 2002), thereby altering the individual's quality of life (Clark 2002). In addition, it has been suggested that pressure ulcers also contribute to increase mortality (Davies 1991; Thomas 1996; Allman 1997; Alarcon 1999; Bo 2003).
Pressure ulcers are a significant financial burden to health care systems (Clark 19920. The Touche Ross report (Touche Ross 1993) estimated the costs of pressure ulcer treatment at between £180 ‐ £321 million annually, with the cost of prevention estimated at £180 ‐ £755 million. It is worthy of note, however, that costs of litigation or quality of life are not included in these estimates. Therefore, at present, the precise economic impact of pressure ulcers has yet to be established (David 1983; Clark 1994; Thompson 1999). None the less, it can be seen that pressure ulcers are common (Dealey 1991; O'Dea 1995; EPUAP 2002) and affect patients in both hospital (Clark 1991) and community settings (Margolis 2002). Furthermore, pressure ulcers are more common in certain patient groups, such as the elderly (Whittington 2000), or those in orthopaedic settings (Versluysen 1986), although other medical conditions also predispose the individual to the development of pressure ulcers (Schoonhoven 2002). Changing population demographics and the rise in the number of elderly patients in the future means that the number of people with pressure ulcers is likely to increase in the years ahead. (Haalboom 2000). It is reasonable to suggest, therefore, that anything that improves ulcer healing outcomes will have a positive impact on both the individual and the health service as a whole (Thompson 1999).
The management of patients with pressure ulcers involves a myriad of different interventions such as nutritional care (EPUAP 2003), pressure reducing/relieving surfaces (Clark 1992; Cullum 2001; McInnes 2004), repositioning (Clark 1998) and skin and wound care (Bergstrom 1994; Flanagan 1998A). Furthermore, in order to reduce the distress for individuals with pressure ulcers, it is essential that their wounds be managed successfully (Fox 2002). Following assessment of both the patient and the wound, the goal of management is to create the optimum local wound environment necessary for healing (Rolstad 2000).
The selection of appropriate topical therapies is widely believed to contribute to healing (Rolstad 2000). Therapies available include wound debridement (Bradley 1999); the application of dressings (Bradley 1999A) and topical antimicrobial agents (O'Meara 2001). Wound cleansing is also regarded as an important component of pressure ulcer care (Hellewell 1997). It is assumed to be necessary to remove dead tissue and foreign bodies from wounds and is usually undertaken before applying a dressing (Flanagan 1998). However, there is uncertainty regarding what constitutes best practice (Fernandez 2004). Different solutions and methods of application are recommended by clinicians and manufacturers, all which result in confusion (Lawrence 1997; Lindholm 1999; Fernandez 2004). Indeed, it is argued that wound cleansing practice is often based on past experience and ritual rather than the best available evidence (Cutting 1990; Glide 1992).
Fernandez et al (Fernandez 2004) have previously conducted a systematic review of wound cleansing, however, the focus of their work was the use of water alone and not all possible solutions used for wound cleansing. In addition, the method of application of the solution was not explored by the authors (Fernandez 2004). It is argued that wound cleansing is a three fold process involving the technique, the solution and the equipment (Young 1995). It remains important therefore, to explore all components of the wound cleansing process as the correct application of the solution may be as relevant as the solution itself (Morison 1989; Singer 1994). In clinical practice, cleansing of pressure ulcers is routinely carried out using a variety of different cleansing solutions including antiseptics, saline and water (Angeras 1992). Furthermore, a variety of cleansing techniques are used including swabbing, showering, immersion or irrigation at high pressure (Lawrence 1997; Lindholm 1999). Therefore, it is necessary to undertake a systematic review of the literature to summarise current evidence. This could provide a contribution to relevant clinical guidelines. In addition, the review will inform research in this important area of patient care.
Objectives
To assess the effects of wound cleansing solutions and techniques on the healing rates of pressure ulcers.
Methods
Criteria for considering studies for this review
Types of studies
Randomised controlled trials (RCTs) comparing wound cleansing with no wound cleansing, or RCTs comparing different wound cleansing solutions or different wound cleansing techniques, will be considered for the review. Controlled clinical trials (CCTs) will only be considered in the absence of any RCTs
Types of participants
Studies involving people of any age, in any health care setting, with existing pressure ulcers (defined as a break in the continuity of the skin) (Nixon 1999).
Types of interventions
For the purposes of this review, cleansing will be defined as the application of fluid to the pressure ulcer to aid removal of exudate, debris, slough and contaminants, but not the use of dressings or mechanical debridement (Towler 2001). Water will be included if, within the relevant study, it has been compared to another solution.
Studies describing the following comparisons will be eligible for the review:
a. Cleansing compared with no cleansing
b. Comparisons between different cleansing solutions
c. Comparisons between different cleansing techniques (e.g., irrigation, swabbing, soaking, immersion).
Types of outcome measures
Trials will be considered if they report at least one of the primary outcomes. Primary outcomes will be an objective measure of pressure ulcer healing, such as time to complete healing; rate of change in pressure ulcer area or volume, proportion of pressure ulcers healed at the completion of the trial period.
Secondary outcomes will be pain, using validated scales where reported, and ease of use of the method of cleansing. Secondary outcomes will only be reported from studies which also report primary outcomes.
Search methods for identification of studies
The following databases will be searched:
1. Cochrane Central Register of Controlled Trials (CENTRAL) ‐ most recent
2. Cochrane Wounds Group Specialised Register ‐ most recent
The Cochrane Wounds Group Specialised Register has been complied through searching of the major health databases including MEDLINE, CINAHL and EMBASE and is regularly updated through searching of the Cochrane Central Register of Controlled Trials, hand searching of wound care journals and relevant conference proceedings.
The following strategy will be used to identify relevant studies:
1. DETERGENTS explode all trees (MeSH)
2. SALINE SOLUTION HYPERTONIC explode all trees (MeSH)
3. POVIDONE‐IODINE explode all trees (MeSH)
4. CHLORHEXIDINE explode all trees (MeSH)
5. HYDROTHERAPY explode tree 1 (MeSH)
6. ANTI‐INFECTIVE AGENTS LOCAL explode all trees (MeSH)
7. DISINFECTION explode all trees (MeSH)
8. ALCOHOL DETERRENTS explode all trees (MeSH)
9. (clean* or wash* or scrub*)
10. (wound* near cleaning)
11. (shower* or bath*)
12. (detergent* or saline or povidone or iodine or betadine)
13. (irrigat* or whirlpool)
14. (chlorhexidine or hibitane or water or alcohol)
15. ANTI‐INFECTIVE AGENTS LOCAL explode all trees (MeSH)
16. DISINFECTION single term (MeSH)
17. antiseptic*
18. disinfectant*
19. solution*
20. soak*
21. SODIUM HYPOCHLORITE explode all trees (MeSH)
22. SOLUTIONS single term (MeSH)
23. hypochlorit*
24. eusol
25. dakin*
26. (potassium next permanganate)
27. (gentian next violet)
28. (hydrogen next peroxide)
29. (benzoyl next peroxide)
30. (#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10 or #11)
31. (#12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20)
32. (#21 or #22 or #23 or #24 or #25 or #26 or #27 or #28 or #29)
33. (#30 or #31 or #32)
34. DECUBITUS ULCER explode all trees (MeSH)
35. (decubitus near ulcer*)
36. (bed near ulcer*)
37. (pressure near ulcer*)
38. (pressure near sore*)
39. (bed near sore*)
40. (#34 or #35 or #36 or #37 or #38 or #39)
41. (#33 and #40)
The bibliographies of all retrieved and relevant publications, identified by these strategies, will be searched for further studies. Drug companies and experts in the wound care field will be contacted to identify any studies not located through the primary search. There will be no restriction on articles on the basis of the language or date of publication.
Data collection and analysis
Study Selection:
Titles and, where available, abstracts of the studies identified by the search strategy, will be assessed by two reviewers independently, for their eligibility (as identified in the selection criteria) for inclusion in the review. Full versions of potentially relevant studies will be obtained and screened against the inclusion criteria by two reviewers independently. Any differences in opinion will be resolved by discussion and where necessary reference to a Wounds Group Editor.
Data Extraction:
Details of eligible studies will be extracted and summarised using a data extraction sheet. Specifically the following information will be extracted:
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Author
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Title
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Source
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Date of study
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Study geographical location
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Care setting
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Type of wound
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Inclusion/exclusion criteria
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Sample size
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Patient characteristics
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Design details
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Study type
-
Allocation
-
Intervention details
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Outcome measures
-
Analysis
-
Results
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Conclusions
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Implications (e.g. for practice)
Two reviewers will conduct data extraction independently and any differences in opinion will be resolved by discussion and where necessary reference to a Wounds Group Editor. If data are missing from reports then attempts will be made to contact the authors to obtain the missing information.
Validity Assessment:
The validity of individual studies will be critically appraised to check methodological rigour, using the quality assessment criteria suggested by Verhagen 1998 and elsewhere (Khan 2001). Specifically the following will be explored:
1. Were the eligibility criteria clearly specified?
2. Was the generation of the randomisation sequence truly random?
3. Was the allocation to treatment groups concealed e.g. sealed opaque envelopes, computerised allocation
4. Were the groups similar at baseline in terms of prognostic factors? If there were differences were these adjusted for in the analysis?
5. Were outcome assessors blinded to treatment allocation?
6. Were the point estimates and measure of variability for each group presented for the primary outcome measure?
7. Were the care providers blinded to treatment allocation?
8. Were participants blinded to treatment allocation?
9. Were participants analysed in the groups to which they were originally allocated (intention to treat analysis) (Hollis 1999).
Synthesis:
Initially a structured narrative summary of the studies reviewed will be conducted. For dichotomous outcomes relative risk plus 95% confidence intervals will be calculated. For continuous outcomes weighted mean difference plus 95% confidence intervals will be calculated.
Clinical heterogeneity will be explored by examining potentially influential factors, e.g. care setting, patient factors or ulcer characteristics. Statistical heterogeneity will be assessed using the I² test (Higgins 2003), which will assess the consistency of effects across studies.
If substantial heterogeneity is detected, the studies will be combined by narrative summary only. Statistical pooling will be carried out on groups of studies which are considered to be sufficiently similar. In the absence of heterogeneity, a fixed effects model will be used, whereas, if there is evidence of some heterogeneity a random effects model will be used.
