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Study Links Kerecis Intact Fish-Skin Grafts to Shorter Hospital Stays

The trial analyzed outcomes across 61 burn centers.

By: Michael Barbella

Managing Editor

Kerecis large meshed fish skin graft. Photo: Business Wire.

Kerecis is sharing new study data that indicates intact fish‑skin grafts significantly reduce the length of hospital stays for severely burned patients needing skin grafts.

The retrospective, propensity-matched, cohort study drew on de-identified data from the American Burn Association’s Burn Care Quality Platform database and compared clinical results for 465 patients who were treated with either Kerecis intact fish-skin grafts or products made from reconstituted cross-linked collagen and synthetic polyurethane. The database is the association’s national registry that captures U.S. burn care outcomes. The study analyzed outcomes across 61 burn centers; data management and statistical analysis were performed independently by BData and Frameshift, respectively—third‑party analytics firms to ensure objective evaluation.

After adjusting for age, gender, total body surface area burned, burn severity, inhalation injury, and trauma diagnosis using generalized linear mixed models, the study found:

  • Hospital length of stay was significantly shorter for patients treated with the intact fish-skin (24.2 days versus 33.5 days with p = 0.005), a statistically significant difference of 9.3 days.
  • The study’s four complication endpoints—sepsis, graft loss, venous thromboembolism, and hospital-acquired pressure injury—were all numerically lower in the intact fish-skin group.
  • Graft loss occurred in 3.2% of patients treated with the intact fish-skin versus 8.3% of those treated with synthetic materials, showing that faster closure was not achieved at the expense of graft quality.

“The real-world comparative data shows that hospital stays are shorter for burn patients treated with intact fish-skin grafts than for those treated with products that do not replicate the structure of native human tissue and are made from reconstituted cross-linked collagen and synthetic polyurethane,” Coloplast Executive Vice President and Kerecis Inventor/Founder/CEO Fertram Sigurjonsson stated. “We are grateful to the American Burn Association for building and maintaining their national registry, and to BData and Frameshift for running the independent analysis.”

A prespecified sensitivity analysis including a broader mixed-product cohort (n = 687) confirmed the primary findings: Patients treated with intact fish-skin achieved an adjusted hospital stay of 27.6 days versus 38.5 days (p < 0.001).

The research was authored by Rajiv Sood, M.D., (Burn and Reconstructive Centers of America and Kerecis Scientific Advisory Board member); Nathanael Hevelone, (Bdata); Olafur B. Davisson, Ph.D., (Frameshift); Ragnar P. Kristjansson, Ph.D. (Frameshift); Bart Phillips, (BData): John C. Lantis II, M.D., (Mount Sinai West, Icahn School of Medicine and Kerecis Scientific Advisory Board member); and Gunnar Johannsson, M.D. (Kerecis).

“The intact fish-skin grafts achieved wound-bed readiness and closure significantly faster than the synthetic products, and the graft loss rate was lower, not higher. The wound bed that forms under fish-skin is not just quick to develop. It holds up. That matters, because speed without reliability is not progress,” said Rajiv Sood, M.D., professor of surgery, Kerecis Scientific Advisory Board member, and the research lead author. “The question this study raises is not simply whether one product closes wounds faster than another. It is whether every burn wound actually requires three to four weeks of staged integration before it can accept a graft. For many of the injuries in this dataset, the answer appears to be no.”

According to a preprint of the study results, the observed difference in hospital length of stay appears to be driven by two factors. One is the ability of fish skin to efficiently prepare a substantive wound bed that is well-suited for skin grafting. The other is that reconstituted and synthetic polyurethane products impose an integration timeline for exceeding wound requirements. The authors note that not every burn benefits from a product that takes several weeks to vascularize. For burns that represent a large portion of clinical practice, injuries serious enough to require a dermal template, but not so extensive that donor site cycling becomes the limiting factor, the analysis indicates that intact fish skin grafts support faster preparation, reliable graft take, and a clean complication profile with practical ease of use.

Kerecis develops intact fish-tissue derived products for cellular therapy, tissue regeneration, and protection. When grafted onto damaged human tissue or implanted, the patented material supports the body’s own processes to heal and regenerate. Because no viral or prion transfer risk exists between Atlantic cod and humans, Kerecis products are only gently processed and retain their similarity to human tissue. The gentle processing preserves the material’s original three-dimensional structure, maintaining its inherent natural strength, complexity, and molecules (such as fatty acids). Clinical studies show that Kerecis products heal wounds faster than competitors. Kerecis is the only global manufacturer of medical devices containing intact fish-tissue and is the fastest growing company in the U.S. xenograft biologics skin market. Products include SurgiBind, SurgiClose, GraftGuide, MariGen, Shield, MariCell, MariGraft, and MariSurgi that address various medical complications. The company uses sustainably sourced Icelandic fish processed with renewable energy. Kerecis is a part of Coloplast, a leading supplier of intimate healthcare products.

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