Authors' objectives:

The objective of this review was 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.

Authors' results and conclusions: A total of 20 randomised controlled trials were included in this review. Due to the diversity of skin substitutes and methods for burn management and the way in which outcomes were reported in the included studies, it was not possible to investigate differences in the effectiveness of bioengineered skin substitutes in partial thickness compared with full thickness burns, in paediatric patients compared to adult patients, and for total burn surface area (TBSA). However, from the available evidence it was possible to draw some conclusions about the different bioengineered skin substitutes considered in the review. For partial thickness burns (less than 15%TBSA), Biobrane and TransCyte appear to be more effective than silver sulfadiazine, avoiding the need for painful daily dressing changes and prolonged hospital stay. Biobrane may also offer cost advantages over other bioengineered skin substitutes. For burns between 20% and 50% TBSA, allogeneic cultured skin and Apligraf combined with autograft both appear to be effective. Dermagraft was also found to be effective for partial and full thickness burns (as effective as allograft); however, the validity of this comparison is questionable as Dermagraft is permanently integrated whereas allograft is a temporary biological dressing. Integra may be better suited to selected patients with burns less than 45% TBSA due to the high rates of infection reported in one study managing patients with burns greater than 45% TBSA. However, in clinical practice, Integra is commonly used in the treatment of major burn injury where a paucity of available donor area precludes early autografting. Its successful take still has to be followed by definitive epidermal closure (by autograft or cultured epithelial autograft). TransCyte appears to be good for facial burns, providing good adherence to the contours of the face. However, considerations with the storage, pre-use preparation and high cost of TransCyte may limit its clinical use. In terms of safety, no major complications were reported with the use of bioengineered skin substitutes for the management of burns or donor sites. The mortality rate was relatively high; however, it was unclear whether these deaths could be attributed to the use of the bioengineered skin substitute or the actual burn injury. In practical terms, this distinction would be difficult to assess since the use of bioengineered skin substitutes is largely confined to patients with larger TBSA burn areas, more complicated pathophysiological insults and significantly poorer prognoses. The available evidence could not resolve the question of the long-term safety of bioengineered skin substitutes with respect to viral infection and prion disease. Thus, at present, autograft remain the gold standard for the management of excised burns as it is effective at closing the wound and there are no issues with graft rejection and viral contamination.

Authors' recommendations: On the basis of the evidence presented in this systematic review, the ASERNIP-S Review Group agreed on the following classifications and recommendations concerning the safety and efficacy of bioengineered skin substitutes for the management of burns: Classifications Evidence rating: The evidence-base in this review is rated as average. The included randomised controlled trials were limited by small sample size and poor reporting of methodological detail. The numerous sub-group analyses and the diversity of skin substitutes limited the ability to draw any conclusions from it. Safety: The evidence suggests that bioengineered skin substitutes, namely Biobrane, TransCyte, Dermagraft, Apligraf, autologous cultured skin, and allogeneic cultured skin, are at least as safe as biological skin replacements or topical agents/wound dressings. The safety of Integra could not be determined as one study reported a high rate of infection and the trial was terminated early. The long-term safety of the use of bioengineered skin substitutes, with respect to viral infection and prion disease, could not be determined. Efficacy: For the management of partial thickness burns, the evidence suggests that bioengineered skin substitutes, namely Biobrane, TransCyte, Dermagraft, and allogeneic cultured skin, are at least as efficacious as topical agents/wound dressings or allograft. Apligraf combined with autograft is 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. Clinical and Research Recommendations Additional methodologically rigorous randomised controlled trials would strengthen the evidence base for the use of bioengineered skin substitutes. However, it is acknowledged that it is unlikely that randomised trials of patients with large, deep burns will be carried out, as these burns are uncommon and usually involve complex clinical decision pathways and possibly the use of several products, which may differ between patients and make comparisons difficult. Therefore, it is recommended that randomised trials of patients with smaller burns be undertaken as these burns are more common and patient accrual should be easier. Furthermore, clinical equipoise should be more easily obtained in these less life-threatening situations. Additionally, studies with sufficient follow-up should be conducted to evaluate the long-term safety of bioengineered skin substitutes and future studies should define and document outcomes for partial and full thickness burns separately. There is also a need for randomised controlled trials on cultured epithelial autograft, in particular cultured epithelial autograft suspensions, as there is a lack of evidence to support its safety and efficacy and its use largely based on anecdote.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.surgeons.org/Content/NavigationMenu/Research/ASERNIPS/default .htm

Year Published: 2006

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Australian Safety and Efficacy Register of New Interventional Procedures-Surgical

Contact Address: ASERNIP-S 24 King William Street, Kent Town SA 5067 Australia Tel: +61 8 8219 0900

Contact Name: racs.asernip@surgeons.org

Contact Email: racs.asernip@surgeons.org

Copyright: Australian Safety and Efficacy Register of New Interventional Procedures - Surgical