Regenerative collagen biomembrane: Interim results of a Phase I veterinary clinical trial for skin repair [version 1; referees: 2 approved, 1 approved with reservations]

Abstract

Background: The availability of commercial tissue engineering skin repair products for veterinary use is scarce or non-existent. To assess features of novel veterinary tissue engineered medical devices, it is therefore reasonable to compare with currently available human devices. During the development and regulatory approval phases, human medical devices that may have been identified as comparable to a novel veterinary device, may serve as predicate devices and accelerate approval in the veterinary domain. The purpose of the study was to evaluate safety and efficacy of the biomembrane for use in skin repair indications. Methods: In the study as a whole (3 year total length), 15 patients (animals), dogs and cats (male/female, 2 cm), with a wound depth equivalent to 2nd/3rd degree burns are to be studied from Day 0 to Day 120-240, post-application of the biomembrane. This interim report covers the 5 patients assessed to date and deemed eligible, of which 3 enrolled, and 2 have completed the treatment. Wound beds were prepared and acellular collagen biomembranes (Eva Scientific Ltd, São Paulo, Brazil) applied directly onto the wounds, and sutured at the margins to the patient's adjacent tissue. Wound size over time, healing rate, general skin quality and suppleness were assessed as outcomes. Qualitative (appearance and palpation) and quantitative (based on Image Analysis of photographs) wound assessment techniques were used. Results: Both patients’ wounds healed fully, with no adverse effects, and the healing rate was comparable in both, maxing out at approximately 1 cm2/day. Conclusions: Early results on the biomembrane's safety and efficacy indicate suitability for skin repair usage in veterinary patients.