TY - JOUR
T1 - Short- and Long-term Outcomes of an Acellular Dermal Substitute versus Standard of Care in Burns and Reconstructions
T2 - A Phase I/II Intrapatient Randomized Controlled Trial
AU - Gardien, Kim L. M.
AU - Pijpe, Anouk
AU - Brouwer, Katrien M.
AU - Stoop, Matthea
AU - Singh, Simarjeet K.
AU - Timmermans, Floyd W.
AU - Vlig, Marcel
AU - van Zuijlen, Paul P. M.
AU - Middelkoop, Esther
N1 - Funding Information: Acknowledgments: This work has been supported by the EuroSkinGraft project, grant agreement number 279024, funded by the EC Seventh Framework Programme theme FP7-HEALTH-2011. Matricel GmbH is a member of the EuroSkinGraft consortium and provided the study product Novomaix. The authors thank the patients for their willingness to participate in the trials and acknowledge the contribution of the surgical team and the research team of the Burn Center Beverwijk, Red Cross Hospital. Publisher Copyright: © Wolters Kluwer Health, Inc. All rights reserved.
PY - 2023/10/1
Y1 - 2023/10/1
N2 - OBJECTIVE: Dermal substitutes promote dermal regeneration and improve scar quality, but knowledge gaps remain regarding their efficacy and indications for use. The authors investigated the safety and short- and long-term efficacy of an acellular dermal substitute in patients with full-thickness wounds. METHODS: This intrapatient randomized controlled, open-label, phase I (safety) and phase II (efficacy) study compared treatment with Novomaix (Matricel GmbH), a dermal collagen/elastin-based scaffold, with split-thickness skin graft (STSG) only. The primary safety outcome was graft take at 5 to 7 days postsurgery. Postsurgical scar quality was assessed by measuring elasticity, color, and scores on the Patient and Observer Scar Assessment Scale at 3 months, 12 months, and 6 years. RESULTS: Twenty-five patients were included, of which 24 received treatment allocation. Graft take and wound healing were statistically significantly lower/delayed in the dermal matrix group compared with STSG alone (P < .004). Serious adverse events were delayed epithelialization in four dermal matrix and three STSG study areas. At 12 months postsurgery, skin extension (P = .034) and elasticity (P = .036) were better for the dermal matrix group compared with the group receiving STSG alone. Other scar quality parameters at 12 months and 6 years did not differ between treatment arms. CONCLUSIONS: The dermal substitute was a safe treatment modality for full-thickness wounds. Compared with STSG alone, time to wound healing was slightly increased. Nevertheless, scar quality at 12 months seemed somewhat improved in the wounds treated with the dermal substitute, indicative of enhanced scar maturation. In the long term, final scar quality was similar for both treatment modalities.
AB - OBJECTIVE: Dermal substitutes promote dermal regeneration and improve scar quality, but knowledge gaps remain regarding their efficacy and indications for use. The authors investigated the safety and short- and long-term efficacy of an acellular dermal substitute in patients with full-thickness wounds. METHODS: This intrapatient randomized controlled, open-label, phase I (safety) and phase II (efficacy) study compared treatment with Novomaix (Matricel GmbH), a dermal collagen/elastin-based scaffold, with split-thickness skin graft (STSG) only. The primary safety outcome was graft take at 5 to 7 days postsurgery. Postsurgical scar quality was assessed by measuring elasticity, color, and scores on the Patient and Observer Scar Assessment Scale at 3 months, 12 months, and 6 years. RESULTS: Twenty-five patients were included, of which 24 received treatment allocation. Graft take and wound healing were statistically significantly lower/delayed in the dermal matrix group compared with STSG alone (P < .004). Serious adverse events were delayed epithelialization in four dermal matrix and three STSG study areas. At 12 months postsurgery, skin extension (P = .034) and elasticity (P = .036) were better for the dermal matrix group compared with the group receiving STSG alone. Other scar quality parameters at 12 months and 6 years did not differ between treatment arms. CONCLUSIONS: The dermal substitute was a safe treatment modality for full-thickness wounds. Compared with STSG alone, time to wound healing was slightly increased. Nevertheless, scar quality at 12 months seemed somewhat improved in the wounds treated with the dermal substitute, indicative of enhanced scar maturation. In the long term, final scar quality was similar for both treatment modalities.
KW - artificial skin
KW - burns
KW - dermal substitute
KW - reconstruction
KW - scar quality
KW - wound healing
UR - http://www.scopus.com/inward/record.url?scp=85171811253&partnerID=8YFLogxK
U2 - https://doi.org/10.1097/ASW.0000000000000040
DO - https://doi.org/10.1097/ASW.0000000000000040
M3 - Article
C2 - 37729164
SN - 1527-7941
VL - 36
SP - 540
EP - 548
JO - Advances in skin & wound care
JF - Advances in skin & wound care
IS - 10
ER -