Authors' objectives:

The objective of this review was to make recommendations on the safety and efficacy of bioengineered skin substitutes for the management of wounds based on a systematic assessment of the peer-reviewed literature. Bioengineered skin substitutes (BSS) either epidermal, dermal or both were compared to standard care/dressings or autografts.

Authors' results and conclusions: In total, 23 RCTs were identified for inclusion in this review. These included eight studies for venous leg ulcers, six studies for diabetic foot ulcers and nine studies of other wounds. Collectively, the definition of success was defined as complete wound closure across all studies; however other outcomes such as wound healing time and percentage of wound closure were not consistently reported, making comparisons between studies difficult. For the indication of venous leg ulcers, Apligraf(TM), cryopreserved cultured allografts, cultured keratinocyte allografts, Dermagraft(TM), EpiDexTM, OASI(TM) Wound Matrix and Promogram(TM), were comparable with the standard treatment in terms of wound healing time, wound closure and decreased ulcer area. There was no difference for pain, recurrence, and wound infection. For the indication of diabetic foot ulcers, the use of BSS appeared to offer an advantage over standard care. Wound healing time appeared to be better overall with the use of BSS (Apligraf(TM), Dermagraft(TM), GraftJacket(TM), Hyalograft(TM) and Laserskin(TM), OrCel(TM) and Promogran(TM) and wound closure appeared to be favourable with the use of Apligraf(TM), GraftJacket(TM), and OrCel(TM). Infection rates were lower and where reported, there was no difference in recurrence between the BSS groups and the comparator. Healing across different wounds was no better with BSS than the relevant comparator, although the evidence suggested that pain might be lower with their use. The evidence suggested that Apligraf(TM) used for micrographic and post excisional wounds produced similar results to standard therapy, and Biobrane(TM) used for donor sites was not as good as the standard therapy. The evidence for Promogran(TM) in the treatment of pressure sores suggested it was as good as the standard therapy, and cultured epidermal allografts were more favourable than the standard therapy in terms of wound healing time and pain, however in several studies the small sample sizes may limit the validity of the conclusions which may be drawn. The BSS with more favourable outcomes commonly had a dermal matrix component in their composition, possibly offering a scaffold in which granulation tissue and angiogenesis may proceed. This may have contributed to the faster time to closure reported in these studies.

Authors' recommendations: Evidence rating The review panel rated the evidence-base in this review as average, limited by generally small sample sizes, short follow-up periods, and lack of methodological rigour. Additionally, the evidence was limited across three indications. Safety The evidence suggests bioengineered skin substitutes for the management of venous leg ulcers, diabetic foot ulcers and other wounds are at least as safe as standard therapies for these indications. Efficacy The efficacy of bioengineered skin substitutes for the management of venous leg ulcers, diabetic foot ulcers and other wounds could not be determined based on the available evidence. Insufficient data on treatment durability were available to establish long-term efficacy. Clinical and research recommendations Additional high quality, prospective, randomised controlled trials with longer follow-up periods would strengthen the evidence base for the use of bioengineered skin substitutes, particularly in terms of recurrence. Standard outcome measures should be developed so that investigators and clinicians can report primary outcomes (specifically in terms of ulcer healing) consistently. Cost-effectiveness studies, taking into consideration the Australian healthcare context, should also be considered.

Authors' methods: Systematic Review

Project Status: Completed

URL for project: http://www.surgeons.org/asernip-s

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 (ASERNIP-S)