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Spincare® System Demonstrates Safety and Efficacy in Treating Partial Thickness Burns.

Josef HaikYehuda UllmannEyal GurErik BirosRachel KornhaberMichelle ClearyDani KruchevskySivan ZissmanYossi NamirMoti Harats
Published in: Journal of burn care & research : official publication of the American Burn Association (2024)
Partial-thickness burns are the most common form of burns, affecting the dermis and possibly resulting in scarring and infection. The Spincare® System is a new device that uses electrospinning technology to create a temporary skin-like matrix that can be applied to wounds. This study evaluated the performance, safety, and efficacy of Spincare in treating superficial to partial-thickness burns not considered for surgery. A prospective single-arm, open-label, multicenter study was conducted in three adult burn units across Israel. Forty-four patients with superficial to intermediate burns of up to 10% of total body surface area (TBSA) were enrolled. Spincare was applied to the wounds, and follow-up visits were performed on days 7, 14, and 21 and months 3 and 6 post-treatment. Thirty-one patients with 36 wounds completed the day 21 visit. The mean wound healing area on day 21 was 97.26± 9.41%, and the mean healing time was 12.8±4.3 days. Only one moderate adverse event was observed concerning the treatment, and it is important to acknowledge the potential progression of this hypertrophic scar into a keloid. This study demonstrated that Spincare is a safe and effective device for treating superficial to intermediate partial-thickness burns. Spincare achieved rapid and complete wound healing with a low incidence of adverse events.
Keyphrases
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  • optical coherence tomography
  • open label
  • clinical trial
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