Avaliação da eficácia do curativo oclusivo com pele de tilápia do-Nilo (Oreochromis Niloticus) na cicatrização de úlceras varicosas

Abstract

Varicose ulcers represent a severe clinical manifestation of chronic venous insufficiency, affecting millions of individuals worldwide and posing a significant therapeutic challenge due to their impaired healing, high recurrence rates, and substantial impact on patients’ quality of life. Although compression therapy remains the gold standard of care, adjuvant treatments have the potential to accelerate the healing process. This study aimed to evaluate the efficacy of an occlusive dressing using Nile tilapia (Oreochromis niloticus) skin in the treatment of varicose ulcers. A phase II, controlled, prospective, randomized, single-center, single-blind clinical trial was conducted at the Vascular Surgery Outpatient Clinic of Walter Cantídio University Hospital, Federal University of Ceará (Brazil). Eight patients with active varicose ulcers were randomly allocated to two groups: one treated with Nile tilapia skin and the other with non-silver polyurethane foam (control group). Primary and secondary endpoints included changes in ulcer area, time to complete healing, pain assessment using a Visual Analog Scale (VAS), quality of life measured by the Charing Cross Venous Ulcer Questionnaire (CCVUQ), and histological analysis. Over a 13-week follow-up period, both groups demonstrated clinical improvement, with complete healing observed in three patients (two in the tilapia group and one in the control group). No statistically significant differences were found between groups regarding ulcer area reduction, pain scores, or quality of life outcomes. Histological analysis revealed the presence of epithelial tissue in the center of the ulcer as early as the biopsy performed 30 days after inclusion in the study in patients from the tilapia skin group, unlike the control group. Cost-effectiveness analysis indicated that the use of tilapia skin may represent a viable alternative due to its lower cost, ease of storage, and sustainable origin as a by-product of aquaculture. These findings support the clinical feasibility of Nile tilapia skin as a promising biomaterial for the treatment of chronic venous ulcers. The intervention achieved comparable clinical outcomes to the control treatment at a lower cost, underscoring the importance of translational research in the development of novel wound care therapies. This work is innovative in applying a low-cost, locally sourced, animal-derived biomaterial to a highly prevalent clinical condition, providing a solid foundation for future multicenter trials and potential applications in other chronic wounds.