This retrospective matched cohort study analyzed deidentified electronic health record data from the U.S. Wound Registry, including 80 patients with Stage 3-4 pressure ulcers (40 per group). Patients were treated with either Intact Fish Skin Graft (IFSG) or Standard of Care (SOC), with outcomes assessed for percent area reduction (PAR), healed status, and healed or improved rate. Follow-up duration was not reported.
Main results showed IFSG was associated with superior PAR (49% vs 34% for SOC, p=0.0028) and a higher healed or improved rate (67.5% vs 55.0%, p=0.0379). Complete healing occurred in 45.5% of IFSG patients versus 33.3% with SOC, but this difference did not reach statistical significance. Effect sizes and absolute numbers for these outcomes were not reported.
Safety and tolerability data, including adverse events, serious adverse events, and discontinuations, were not reported. Key limitations include a high-risk, real-world cohort with only 37.5% ambulatory patients and a high prevalence of multiple concurrent wounds, which may affect generalizability. Funding and conflicts of interest were not reported.
Practice relevance is that this study supports the use of IFSG as an effective advanced therapy for hard-to-heal pressure ulcers, based on observational evidence. However, the retrospective design and lack of safety data mean results should be interpreted with restraint, and the non-significant difference in complete healing highlights the need for further research to confirm benefits.
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ObjectiveTo evaluate the real-world effectiveness of Intact Fish Skin Graft (IFSG) compared with standard of care (SOC) in the treatment of Stage 3-4 pressure ulcers, using clinically meaningful outcomes including wound healing rate and percent area reduction (PAR).
Materials and MethodsA retrospective matched cohort study was conducted using deidentified electronic health record (EHR) data from the U.S. Wound Registry. Patients with Stage 3-4 pressure ulcers treated with IFSG (n=40) were compared to a matched SOC control group (n=40). 1:1 covariate matching was performed to reduce confounding across key patient and wound characteristics, including age, mobility status, comorbidities (e.g., diabetes, peripheral artery disease), and wound features (age, size, location, and depth). Outcomes included healed status, healed or improved rate, and percent area reduction (PAR).
ResultsThe study population represented a high-risk, real-world cohort (n=40 per group), with only 37.5% ambulatory patients and a high prevalence of multiple concurrent wounds. IFSG treatment demonstrated superior clinical outcomes compared to SOC:
O_LIHealed or improved: 67.5% (IFSG) vs 55.0% (SOC) (p=0.0379)
C_LIO_LIHealed: 45.5% (IFSG) vs 33.3% (SOC)
C_LIO_LIPercent area reduction (PAR): 49% (IFSG) vs 34% (SOC) (p=0.0028)
C_LI
These findings indicate statistically significant improvements in percent area reduction and in the proportion of wounds that were healed or improved with IFSG. The proportion achieving complete healing was numerically higher with IFSG than with SOC, but this difference did not reach statistical significance.
ConclusionIn this real-world matched cohort analysis, Intact Fish Skin Graft demonstrated superior effectiveness compared to standard of care in the management of Stage 3-4 pressure ulcers, with improvements in healing-related outcomes and percent area reduction. These results support the use of IFSG as an effective advanced therapy for hard-to-heal pressure ulcers.