Comparison of intact fish-skin graft to standard of care for treatment of venous leg ulcers using real-world data from the USWR with 1:1 matching on 14 wound/patient factors
DOI:
https://doi.org/10.63676/j0khvd18Keywords:
Venous leg ulcers; Real-World Evidence, chronic wounds; intact fish skin graft; tissue re-generation.Abstract
Background: Venous leg ulcers (VLUs) impose substantial morbidity and Medicare spending, yet many real-world ulcers remain refractory to standard of care (SOC). Intact fish-skin graft (IFSG) is a biologic graft used for chronic (hard-to-heal) wounds. We evaluated the comparative effectiveness of IFSG versus SOC in routine practice using a specialty wound registry with real world evidence design features intended to minimize bias.
Methods: We performed a retrospective, target-trial–emulating, 1:1 propensity score–matched comparative-effectiveness study within the U.S. Wound Registry (USWR). Matching used 14 pre-specified patient- and wound-level covariates (including mobility as a measure of frailty and number of concomitant wounds).
Results: The matched cohort included 129 IFSG-treated VLUs and 129 SOC-treated VLUs. Baseline balance was excellent by standardized mean differences; small residual differences favored SOC; IFSG wounds were older and trended larger. Healing occurred in 85.3% of IFSG wounds (110/129) versus 75.2% of SOC wounds (97/129); the absolute difference (+10.1%) was just below statistical significance (p=0.0801). SOC-treated VLUs increased in size on average more than IFSG-treated VLUs (p=0.0036).
Conclusion: In a national wound registry with rigorous cohort construction, aligned index timing, comprehensive covariate control, and structured outcome capture, IFSG demonstrated favorable real-world effectiveness versus SOC for VLUs with a trend to-wards more healed wounds and a statistically significant lower average wound expansion. The high healing rate in the SOC arm is plausibly explained by baseline advantages (shorter duration, smaller area, and 'never-advanced-therapy' selection) as well as the absence of a set follow-up duration that typically extended until healing, a competing event, or administrative end of observation.
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