A Retrospective Matched-Cohort Study of 3994 Lower Extremity Wounds of Multiple Etiologies Across 644 Institutions Comparing a Bioactive Human Skin Allograft, TheraSkin, Plus Standard of Care, to Standard of Care Alone

Authors

Geoff C Gurtner
Aimee D Garcia
Katie Bakewell
Jason B Alarcon

Publication Date

2-1-2020

Journal

International Wound Journal

DOI

10.1111/iwj.13231

PMID

31729833

PMCID

PMC7004012

PubMedCentral® Posted Date

11-15-2019

PubMedCentral® Full Text Version

Post-print

Published Open-Access

yes

Keywords

Adult, Aged, Aged, 80 and over, Allografts, Amputation, Surgical, Bandages, Cohort Studies, Female, Humans, Lower Extremity, Male, Middle Aged, Retrospective Studies, Standard of Care, Transplantation, Homologous, United States, Wound Healing, Wounds and Injuries, allograft, amputation, healing, recidivism, wounds

Abstract

Most chronic wounds are related to comorbidities, for which no clinical trials are performed. This retrospective propensity matched-cohort study examined data from 2 074 000 lower extremity wounds across 644 institutions to determine the effectiveness of TheraSkin plus standard of care (SOC; n = 1997) versus SOC alone (n = 1997). Multivariate modelling comparing outcomes such as healing rates, percent area reductions (PARs), amputations, recidivism, treatment completion, and medical transfers were evaluated. A higher proportion of wounds in the treatment group compared with the controls were more likely to close (68.3% versus 60.3%), particularly wounds with exposed structures (64% versus 50.4%) and with lower recidivism at 6 months (24.9% versus 28.3%). The control group was 2.75x more likely to require amputation than the treatment group. The combination of propensity matching and logistic regression analysis on a particularly large database demonstrated that wounds treated with TheraSkin had higher healing rates, higher PARs (78.7% versus 68.9%), fewer amputations, lower recidivism, higher treatment completion (61.0% versus 50.6%), and lower medical transfers (16.1% versus 23.5%) than SOC alone. This study considered data from complex wounds typically excluded from controlled trials and supports the idea that real-world evidence studies can be valid and reliable.