IJTR · 2025

Evaluation of intact fish skin grafts plus standard care in the treatment of venous leg ulcers: an abstract

Serena, T.E., Tramelli, B., Booker, B., King, E., Shi, D., & Lantis, J.C.

International Journal of Tissue Repair (IJTR), ABSTRACT of the THOR interim analysis, 2 pages

In brief

This interim analysis of the THOR randomized controlled multicenter trial compared an intact fish skin graft plus standard of care (SOC) with SOC alone for nonhealing venous leg ulcers, with complete wound closure at 12 weeks, confirmed by blinded independent review, as the primary endpoint. In the intent-to-treat population, 47.6% of ulcers closed with the fish skin graft versus 21.7% with SOC alone, a difference that was not statistically significant (p = 0.07). The graft arm showed higher mean wound area reduction, and the authors describe a positive trend at this interim stage.

SerenaGroup is running this trial for Kerecis.

Plain-language summary by SerenaGroup. See the full text for complete methods and results.

Abstract

Evaluation of intact fish skin grafts plus standard care in the treatment of venous leg ulcers: an interim analysis of the THOR trial Thomas E Serena,1 MD | Brianna Tramelli1 | Barkley Booker1 | Emily King,1 MS | Dereck Shi,1 MS | John C. Lantis2 MD 1 SerenaGroup Inc., Cambridge, MA, USA | 2Mount Sinai West Hospital, New York, NY, USA

Keywords

Cellular acellular and matrix-like productsvenous leg ulcerinterim analysischronic woundsclinical trial design

Evaluation of intact fish skin grafts plus standard care in the treatment of venous leg ulcers: an abstract

In brief

Abstract

Keywords

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