A Retrospective Propensity Score Matched Cohort Study Comparing Intact Fish Skin Graft with Synthetic and Biosynthetic Dermal Substitutes for Acute Burn Injuries Requiring Dermal Substitution and Autografting: Outcomes from the American Burn Association Registry

Abstract

Objective The objective of this study was to compare hospital length-of-stay and other clinical outcomes between intact fish skin graft (IFSG; Graftguide, Kerecis, Arlington, VA) and synthetic/biosynthetic dermal substitutes (SSS; Integra Dermal Regeneration Template and NovoSorb Biodegradable Temporizing Matrix) in propensity score–matched burn patients using the American Burn Association Burn Care Quality Platform.

Methods This retrospective cohort study identified adult patients treated with a single dermal substitute product during hospitalization for acute burn injury. Patients receiving IFSG (n = 93) were matched 1:4 to patients receiving SSS (n = 372) using nearest-neighbor propensity score matching on the logit scale. Matching covariates included total body surface area burned (TBSA), patient age, sex), burn severity classification, inhalation injury, and trauma diagnosis. The primary outcome was hospital length of stay (LOS), analyzed using a gamma generalized linear mixed model (GLMM). Secondary outcomes included the incidences of sepsis, graft loss, venous thromboembolism (VTE), and hospital-acquired pressure injury (HAPI). A prespecified sensitivity analysis was performed using a broader mixed-product cohort.

Results A total of 93 IFSG-treated patients from 17 burn centers admitted between the years 2019 and 2025 were matched 1:4 to 372 SSS-treated patients from 44 centers. Unadjusted mean LOS was 24.1 days (median 20, IQR 11–32) in the IFSG-treated group and 36.7 days (median 31, IQR 17–52) in the SSS-treated group representing a 12.6-day reduction. GLMM-adjusted estimated marginal mean LOS was 24.2 days (95% CI, 20.0–29.4) for IFSG versus 33.5 days (95% CI, 30.0–37.6) for SSS (ratio 0.723; p = 0.00245), representing a 9.3-day reduction. Sepsis (1.1% vs 4.6%), graft loss (3.2% vs 8.3%), VTE (2.2% vs 2.7%), and HAPI (2.2% vs 3.8%) were all numerically lower in the IFSG-treated arm; although GLMM-adjusted odds ratios were not statistically significant for any individual complication. The mixed-cohort sensitivity analysis (n = 229 IFSG vs 458 SSS across 67 centers) confirmed the primary finding with GLMM-adjusted LOS ratio 0.716 (p = 0.0001).

Conclusions In this propensity score–matched analysis of the ABA registry, IFSG was associated with a statistically significant and clinically meaningful reduction in hospital length of stay compared with synthetic/biosynthetic dermal substitutes, in requiring dermal substitution and autografting, with all complication rates, sepsis, graft loss, VTE, and HAPI, numerically lower in the IFSG-treated arm. The shorter hospitalization was not achieved at the expense of safety. These findings support IFSG as a viable alternative to synthetic dermal substitutes in burns requiring dermal substitution and autografting. Prospective studies are warranted particularly in larger burns requiring staged reconstruction.

Competing Interest Statement

This study was funded by Kerecis, LLC. Dr. Gunnar Johannsson is the Senior Vice President and Medical Director of Kerecis, LLC. Dr. Rajiv Sood serves as a paid consultant to Kerecis, LLC. Nathanael D. Hevelone, MPH and Bart D. Phillips, MS received funding from Kerecis, LLC for the work described in this paper. Dr. Olafur B. Davidsson and Dr. Ragnar P. Kristjansson are paid consultants for Kerecis, LLC. Dr. John C. Lantis II is Chairman of the Scientific Advisory Board for Kerecis, LLC.

Funding Statement

This study was funded by Kerecis, LLC.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

IRB exemption requested from WCG IRB Connexus. This study utilized de-identified patient data from the ABA Burn Care Quality Platform (BData), a registry maintained by the American Burn Association that collects standardized clinical and outcome data from 80 participating burn centers across the United States.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

Data in this study is generally unavailable with possible exceptions.

Comments (0)

No login
gif