Abstract
Introduction
Full-thickness thermal burns may require staged procedures with temporary coverage to ensure the wound bed is optimized for autografting. A potential dermal substitute for thermal injury is fish skin grafts. These are made in Iceland from freeze dried, sterilized, decellularized skin of North Atlantic cod (Gadus morhua). The gentle processing of the fish skin removes the risk of viral disease transmission to humans and retains its naturally occurring Omega3 fatty acids which are known for their pain and inflammation modulating effects. Fish skin graft has a shelf life of 3 years at room temperature, whereas cadaver skin, the current standard of care at many institutions, has to be cryopreserved, is donor derived, and contains only trace amounts of Omega3. While fish skin graft has been cleared by the FDA as a medical device for use in acute, surgical, chronic wounds, and partial thickness burns, it has not yet been indicated for use in full-thickness burns. The purpose of this clinical trial is to assess the safety and efficacy of decellularized, freeze dried fish skin as an alternative to cadaveric skin (standard of care) for temporary coverage in the setting of a full-thickness burn requiring staged grafting.
Methods
Patients with full thickness burns to their extremities and/or chest were randomized to have two adjacent areas (70–140 cm2 each) covered with either fish skin or cadaver skin for one week following excision. Patients then received a split thickness skin graft (STSG). Healing was observed by blinded assessors for each area weekly for three weeks, with a scarring assessment completed at 3 months post STSG. Background pain was measured by a visual analogue scale (VAS) for pain and wounds were photographed at each time point.
Results
Five patients are included in this initial analysis and all completed the 3-month post STSG follow up. TBSA ranged from 8–37%.
The fish skin treated area was assessed to be 90% healed at the same timeframe or earlier than cadaver treated areas in all subjects. There was a trend towards a reduction in pain in the fish skin covered areas. One patient was unable to give a pain score due to heavy sedation.
Adverse events were reported in all five patients, but none were associated with the use of the investigational product. Graft failures were observed in two cadaver skin covered areas and one partial failure in a fish skin covered area.
Conclusions
Results from this trial so far indicate that the fish skin is safe and non-inferior to cadaver skin as an early coverage for full thickness burns. Enrollment in this study is still ongoing, and patients will be followed up for 12 months.