Elsevier

Burns

Volume 33, Issue 8, December 2007, Pages 946-957
Burns

Review
Bioengineered skin substitutes for the management of burns: A systematic review

https://doi.org/10.1016/j.burns.2007.03.020Get rights and content

Abstract

Objective

To assess the safety and efficacy of bioengineered skin substitutes in comparison with biological skin replacements and/or standard dressing methods in the management of burns, through a systematic review of the literature.

Methods

Literature databases were searched up to April 2006, identifying randomised controlled trials.

Results

Twenty randomised controlled trials were included in this review. The numerous sub-group analyses and the diversity of skin substitutes limited the ability to draw any conclusions from it. However, the evidence suggested that bioengineered skin substitutes, namely Biobrane®, TransCyte®, Dermagraft®, Apligraf®, autologous cultured skin, and allogeneic cultured skin, were at least as safe as biological skin replacements or topical agents/wound dressings. The safety of Integra® could not be determined. For the management of partial thickness burns, the evidence suggested that bioengineered skin substitutes, namely Biobrane®, TransCyte®, Dermagraft®, and allogeneic cultured skin, were at least as efficacious as topical agents/wound dressings or allograft. Apligraf® combined with autograft was at least as efficacious as autograft alone. For the management of full thickness burns, the efficacy of autologous cultured skin could not be determined based on the available evidence. The efficacy of Integra® could not be determined based on the available evidence.

Conclusions

Additional methodologically rigorous randomised controlled trials with long-term follow-up would strengthen the evidence base for the use of bioengineered skin substitutes.

Introduction

Burn injuries are among the most complex and harmful physical injuries to evaluate and manage. In addition to pain and distress, a large burn will leave the patient with visible physical scars and invisible psychological sequelae. Currently, autograft is the best replacement for lost skin. However, in clinical practice this is not always possible, particularly in large total body surface area burns, as there is often an insufficient amount of skin for autografting available at the time of burn excision, or the physiological condition of the patient precludes the harvesting of skin. Allografts and xenografts can be used to provide temporary wound coverage, but there are issues with graft rejection, availability, cultural and ethical implications and the possibility of disease transfer [1].

Bioengineered skin substitutes (biosynthetic skin substitutes and autologous cultured/non-cultured skin engineering products) were developed as an adjunct or alternative to the use of the patient's own skin (autograft), the current gold standard [2]. They are designed to close the wound, temporarily or permanently, providing a mechanical barrier to infection and fluid loss. They also possess various biological and pharmacological properties of human skin which allow and/or promote new tissue growth and optimise the conditions for healing [3].

Biosynthetic skin substitutes provide immediate wound cover, are available in large quantities and have a negligible risk of cross-infection (which is potentially associated with the use of allografts and xenografts). Furthermore, the use of autologous cells in the cultured skin products has the advantage of immunological safety. However, most skin substitutes are expensive and considerable experience is required to decide which material is appropriate for any given situation.

Due to the diversity of bioengineered skin substitutes available, there is uncertainty regarding their safety and effectiveness in comparison with standard wound management, either with biological skin replacements or standard wound dressings. To address this issue, a systematic review of the safety and efficacy of bioengineered skin substitutes was undertaken and we present here the findings of the review.

Section snippets

Review process

The surgical director of the Australian Safety and Efficacy Register of New Interventional Procedures-Surgical chaired the review group of three surgeons and one researcher.

Literature search strategies

A systematic search was conducted of Ovid MEDLINE, EMBASE and CINAHL, and Entrez-PubMed, Current Contents, and the Cochrane Library using Boolean search terms, from the inception of the databases until April 2006. The York (UK) Centre for Reviews and Dissemination databases, Clinical Trials database, National Research

Description of included studies

A total of 20 randomised controlled trials (19 level II and 1 level III-1) were included in this review (see Table 1). The bioengineered skin substitutes from the included studies were categorised in this review by type, as each are comprised of different components, have different functions and are used at different time points in the various clinical treatment pathways for burns. The quality of the available evidence was average. The included randomised controlled trials were limited by small

Study limitations

This review of bioengineered skin substitutes was limited by the quantity and quality of the available evidence which was rated as average. Despite the inclusion of 20 RCTs, a number of factors limited the conclusions which could be drawn and prevented statistical pooling: the diversity of skin substitutes and management methods for burns; the lack of a standard comparator; the differences in the techniques used to measure wound healing time and wound closure across the studies.

The majority of

Conclusions

Despite the inclusion of 20 randomised controlled trials, which should have minimised bias in the reporting of outcomes, these trials were characterised by generally poor reporting of methodological detail and small sample sizes. Consequently, it was difficult to be confident in the validity of some of the findings. More rigorous RCTs are required comparing burn coverings with similar properties to enable valid comparisons of outcomes.

The evidence suggests that bioengineered skin substitutes,

Conflict of interest statement

None of the authors declared a conflict of interest, including financial or personal relationships with other people or organisations that could inappropriately bias their work.

Acknowledgements

We would like to thank Dr Rebecca Tooher and Ms Amber Watt for their editing assistance in this assessment.

The full Australian Safety and Efficacy Register of New Interventional Procedures-Surgical (ASERNIP-S) systematic review of this procedure with data extraction tables can be found at the ASERNIP-S website: www.surgeons.org/asernip-s/.

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