RNRCTAdvances in skin & wound care2023

Short- and Long-term Outcomes of an Acellular Dermal Substitute versus Standard of Care in Burns and Reconstructions: A Phase I/II Intrapatient Randomized Controlled Trial.

Kim L M Gardien, Anouk Pijpe, Katrien M Brouwer and 6 others

PMID 37729164

WHAT IT FOUND

The 3-month elasticity outcome showed no difference between dermal matrix plus graft and graft alone in burns or reconstruction.

Early graft take and wound closure were worse with matrix, while 12-month elasticity favoured it.

Key findings

01At 5 to 7 days, graft take was 80% with dermal matrix plus meshed skin graft versus 95% with meshed skin graft alone, and complete closure took 28 days versus 16 days.

02Scar elasticity did not differ at 3 months or 6 years, but final deformation and extensibility favoured dermal matrix at 12 months.

03Mean observer and patient scar assessment scores did not differ at 3 months, 12 months, or 6 years.

STILL TO COME

How it was doneWhat they foundWhat it means for RNs

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What it does not show

Only 24 patients were randomized from 25 included because one died before randomization, and phase I and phase II data were pooled, so the sample was small for efficacy conclusions. Surgeons were not blinded, and the dermal matrix may have remained visible early, which could affect wound care and assessment. The phase II primary elasticity outcome at 3 months was not significant; positive elasticity findings were at 12 months. Long-term follow-up included 15 of 20 eligible patients, so attrition may affect 6-year results. All patients received topical antimicrobial dressings or treatments, making infection-related differences hard to separate. Mesh expansion was 1:1.5, and the authors note benefits may differ with larger expansion rates.

Declared interests

The authors disclosed no other financial relationships.

The easy way to misread this

Do not conclude the dermal matrix improves scar quality overall. The 3-month elasticity outcome was not significant, early graft take and wound closure were worse, and only 12-month elasticity measures favoured it.

Read it on PubMed →

Short- and Long-term Outcomes of an Acellular Dermal Substitute versus Standard of Care in Burns and Reconstructions: A Phase I/II Intrapatient Randomized Controlled Trial. — Applied Evidence