The effectiveness of moisturizers for the management of burn scars following severe burn injury: a systematic review protocol Tanja Klotz, BAppSc (OT), BSc 1 Rochelle Kurmis, BND APD, CF JBI 1 Zachary Munn, BMedRad (Nuc Med),GradDipHlthSc, PhD 2 Kathryn Heath, BAppSc (Phty), MAppSc (Phty) 1 John Greenwood, BSc (Hons), MBChB, MD, DHlthSc, FRCS (Eng), FRCS (Plast), FRACS 1 1 Adult Burns Service, Royal Adelaide Hospital, Adelaide 2 School of Translational Health Science, The Joanna Briggs Institute, Faculty of Health Sciences, The University of Adelaide, South Australia Corresponding author: Rochelle Kurmis Rochelle.Kurmis@health.sa.gov.au Review question/objective The objective of this review is to identify and synthesize the best available evidence on the effectiveness of moisturizer use for the management of burn scars following severe burn injury. More specifically, the review will focus on the following question(s): What are the recommended types of moisturizers used on scar formation in patients who have sustained a burn injury? What is the effectiveness of moisturizer use on scar outcomes, including formation, breakdown, patient acceptance and water loss, following severe burn injury? Background The common mantra that patients often leave a burns unit with is moisturize and massage. The modality of scar massage is well-recognized as an important part of burn scar management. 1 Following the maturation of scar tissue after a burn injury, massage is commenced as part of the standard care offered to victims of burn injury. The premise behind massage is that it maintains joint mobility, aids softening and remodelling of scar tissue and improves scar elasticity through loosening adhering fibrous tissue, whilst also assisting with pruritus, a common side effect of healing following burn injury. 1 When healing skin has gained sufficient strength to tolerate massage with the use of friction, scar massage is routinely performed with the use of lubricants, 1 which commonly consist of skin moisturizers. Although existing literature provides guidance on the use of products that are fragrance free and free from other skin irritants, 1 little is known in regards to recommendations on the ideal composition of moisturizers for optimal scar management. Products used should not have a negative effect on skin/scar integrity, such as breakdown of the skin. Various products have been reported for use in practice as well as in literature doi: 10.11124/jbisrir-2014-1853 Page 212
on scar management, include aqueous cream BP, bees wax and herbal oil creams, 2 silicone based creams and paraffin/petroleum based products. Aqueous cream BP is a readily available and relatively cheap emollient that is fragrance and color free. Its formulation consists of purified water, white soft paraffin, cetearyl alcohol and sodium lauryl sulfate (SLS), liquid paraffin, and phenoxyethanol. Previously reported as the standard treatment for moisturization and massage in some burns units, 2 aqueous Cream BP contains SLS, which has been documented as a known skin irritant. 3-6 The application of aqueous cream BP in subjects with healthy skin, following the removal of increasing amounts of their stratum corneum, has also been shown to increase transepidermal water loss (TEWL) and disrupt the normal skin maturation process. 7 Chronic application of aqueous cream BP was also shown in this study to increase the rate of skin turnover as well as contribute to thinning of the stratum corneum. 7 This is of particular concern in burn injury as scar tissue has been shown to have increased TEWL when compared with healthy skin, 8. In contrast, a comparison study between aqueous cream BP and bees wax and herbal oil cream indicated that newly healed skin in the bees wax and herbal oil group appeared supple and moist when compared to the aqueous BP group. Healing skin in the latter group was reported as appearing dry in contrast. 2 Although the study had a small sample size, it did demonstrate that bees wax and herbal oil cream provided a greater reduction in the symptom of itch following burn injury along with a decreased use of antipruritic medications when compared to aqueous cream BP. 2 The aim of this study was to compare the effectiveness of both preparations in the management of post burn itch. Anecdotal reports of alternate formulations, including silicone and petroleum based products (such as Vaseline), being used by burns units around the world are often reported at burns symposiums and forums, with their selection appearing to be based on historical practice, clinician preference, patient tolerance or beliefs in herbal medicine. Pressure garment manufacturers often also recommend the avoidance of petroleum based emollients where pressure garments are worn as they may reduce the elasticity of the pressure garment, in turn reducing its effectiveness and the life of the garment. No review on the optimal lubricant for burn scar management has been identified to date via searches of the Cochrane Database of Systematic Reviews, Joanna Briggs Institute Database of Systematic Reviews and Implementation Reports and PubMed database, so this review aims to elucidate the best available evidence on the choice of moisturizer in the management of burn scars. Keywords Burns, moisturizer, scar formation, scar management, thermal injury Inclusion criteria Types of participants This review will consider studies that include patients of any age who have sustained a burn injury of any size and have been admitted to a burns unit for the management of their injury. doi: 10.11124/jbisrir-2014-1853 Page 213
Types of intervention(s)/phenomena of interest This review will consider studies that evaluate any type of moisturizing cream following burn injury. Participants will have received standard burns wound management. Studies that include moisturizer use in combination with other predefined scar management strategies will be considered for inclusion. The moisturizer creams may be compared to placebo, usual care, other interventions or a different type of moisturizer. Types of outcomes Primary outcomes that will be examined in this review include scar formation and skin breakdown. These outcomes may be measured by objective tools or subjective scales. Secondary outcomes that will be examined in this review include patient product acceptance/compliance, and TEWL. These outcomes may be measured by objective tools (such as Tewameters) or subjective scales. Types of studies This review will primarily consider experimental study designs including randomized and pseudo-randomized controlled trials. Where randomized controlled trials are not available, this review will consider other study designs including non-randomized controlled trials, quasi-experimental, before and after studies, prospective and retrospective cohort studies, case series and case studies for inclusion. Search strategy The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilized in this review. An initial limited search of PubMED and CINAHL will be undertaken followed by an analysis of the text words contained in the title and abstract, and of the index terms used to describe article. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference list of all identified reports and articles will be searched for additional studies. All studies identified and published in English will be considered for inclusion in this review. No date limits will be applied. The databases to be searched include: PubMED, CINAHL, EMBASE and Web of Science. The search for unpublished studies will include: clinicaltrials.gov (US Clinical Trials Register), www.anzctr.org.au (Australian and New Zealand Clinical Trials Register), www.controlled-trials.com (European Clinical Trials Register), Mednar, www.opengrey.eu, and Cochrane Central Register of Controlled Trials (CENTRAL). Initial keywords to be used will be: moisturizer, moisturiser, burn injury, burn, burns, thermal injury, scar, trans epidermal water loss, aqueous cream, emollient, hydration doi: 10.11124/jbisrir-2014-1853 Page 214
Assessment of methodological quality Papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer. Data collection Data will be extracted from papers included in the review using the standardized data extraction tool from JBI-MAStARI (Appendix II). For missing information or data that needs clarification, the authors of primary studies will be contacted. Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer. The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. Data synthesis Quantitative data will, where possible be pooled in statistical meta-analysis using JBI-MAStARI. All results will be subject to double data entry. Effect sizes expressed as odds ratio (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed statistically using the standard Chi-square and also explored using subgroup analyses based on the different study designs included in this review where and if appropriate. Subgroup analysis may also be performed based on different interventions or population groups. Where statistical pooling is not possible the findings will be presented in narrative form including tables and figures to aid in data presentation where appropriate. Conflicts of interest The authors have no known conflicts of interest to declare. doi: 10.11124/jbisrir-2014-1853 Page 215
References 1. Serghiou MA, Ott S, Farmer S, Morgan D, Gibson P, Suman OE. Comprehensive rehabilitation of the burn patient in Herndon D. Total Burn Care. Third ed. Philadelphia: Saunders, Elsevier Inc; 2007. 2. Lewis PA, Wright K, Webster A, Steer M, Rudd M, Doubrovsky A, et al. A randomized controlled pilot study comparing aqueous cream with a beeswax and herbal oil cream in the provision of relief from postburn pruritus. Journal of Burn Care & Research : official publication of the American Burn Association. 2012 Jul-Aug;33(4):e195-200. 3. Bruynzeel DP, van Ketel WG, Scheper RJ, von Blomberg-van der Flier BM. Delayed time course of irritation by sodium lauryl sulfate: observations on threshold reactions. Contact Dermatitis. 1982 Jul;8(4):236-9. 4. Dahl MV, Trancik RJ. Sodium lauryl sulfate irritant patch tests: degree of inflammation at various times. Contact Dermatitis. 1977 Oct;3(5):263-6. 5. Geier J, Uter W, Pirker C, Frosch PJ. Patch testing with the irritant sodium lauryl sulfate (SLS) is useful in interpreting weak reactions to contact allergens as allergic or irritant. Contact Dermatitis. 2003 Feb;48(2):99-107. 6. Loffler H, Pirker C, Aramaki J, Frosch PJ, Happle R, Effendy I. Evaluation of skin susceptibility to irritancy by routine patch testing with sodium lauryl sulfate. European Journal of Dermatology : EJD. 2001 Sep-Oct;11(5):416-9. 7. Mohammed D, Matts PJ, Hadgraft J, Lane ME. Influence of Aqueous Cream BP on corneocyte size, maturity, skin protease activity, protein content and transepidermal water loss. The British Journal of Dermatology. 2011 Jun;164(6):1304-10. 8. Suetake T, Sasai S, Zhen YX, Ohi T, Tagami H. Functional analyses of the stratum corneum in scars. Sequential studies after injury and comparison among keloids, hypertrophic scars, and atrophic scars. Archives of Dermatology. 1996 Dec;132(12):1453-8. doi: 10.11124/jbisrir-2014-1853 Page 216
Appendix I: Appraisal instruments MAStARI appraisal instrument doi: 10.11124/jbisrir-2014-1853 Page 217
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Appendix II: Data extraction instruments MAStARI data extraction instrument doi: 10.11124/jbisrir-2014-1853 Page 219
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