Clinical Trial Shows that Treatment with Kerecis Intact Fish-Skin Grafts Shortens Hospital Stays for Severely Burned Patients

The trial compared hospital stay duration of severely burned patients treated with intact fish-skin grafts and patients treated with products that do not replicate the structure of native human tissue and are made from reconstituted cross-linked collagen and synthetic polyurethane.

ORLANDO, Fla.--(BUSINESS WIRE)--Kerecis, the company pioneering the use of sustainably sourced fish‑skin in tissue regeneration, announced today at the American Burn Association Annual Meeting, that new study data shows that intact fish‑skin grafts significantly reduce hospital length of stay for severely burned patients requiring skin grafting. The conference is being held at the Rosen Shingle Creek Conference Hotel in Orlando, FL, where Kerecis is exhibiting at Booth 707.

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 burn care outcomes across the United States. 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.

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

The new clinical research will be presented by Rajiv Sood, MD, FACS during a symposium lecture titled “Decoding Fish Skin in Burn Care: Treatment Algorithms, Mechanism of Action, and Real‑World Application,” held in the Conway Room at the Rosen Shingle Creek Conference Hotel today from 5:40 PM to 6:30 PM EDT.

The research was authored by Rajiv Sood, MD, FACS (Burn and Reconstructive Centers of America and Kerecis Scientific Advisory Board member), Nathanael Hevelone, MPH (Bdata), Olafur B. Davisson, PhD (Frameshift), Ragnar P. Kristjansson, PhD (Frameshift), Bart Phillips, MS (BData), John C. Lantis II, MD, FACS (Mount Sinai West, Icahn School of Medicine and Kerecis Scientific Advisory Board member), and Gunnar Johannsson, MD (Kerecis). A preprint of the study results is currently available.

“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,” said Fertram Sigurjonsson, Coloplast Executive Vice President and Kerecis Inventor, CEO & Founder and added “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.”

“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, MD, FACS, professor of surgery, member of Kerecis Scientific Advisory Board and the research lead author and added, “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.”

The preprint discusses that the observed difference in hospital length of stay appears to be driven by two factors. One is the ability of fish-skin to prepare a substantive wound bed efficiently, well suited for skin grafting. The other is that reconstituted and synthetic polyurethane products impose an integration timeline that may exceed what many of these wounds require. 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.

About Kerecis

Kerecis, founded by Fertram Sigurjonsson, 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™, MariSurgi™ that address various medical complications. Committed to the UN Sustainable Development Goals, Kerecis uses sustainably sourced Icelandic fish processed with renewable energy. Kerecis is a part of Coloplast, a leading supplier of intimate healthcare products. For more information about Kerecis and its clinical research, visit www.kerecis.com.

Trademarks and registered trademarks are the property of their respective owners.