Use of Nile Tilapia Fish Skin as a Xenograft for Burn Treatment: Phase III Study

PHASE3CompletedINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

April 3, 2017

Primary Completion Date

October 24, 2018

Study Completion Date

October 24, 2018

Conditions
Burns
Interventions
DEVICE

Nile Tilapia Fish Skin

In the search of new therapies for burns, the skin of Brazil's most cultivated fish, the Nile tilapia, which was mostly a waste product (although sometimes used as a resistant material for artisanal handicraft), was suggested as a possibility for the development of a low-cost xenograft. Apart from non-infectious microbiota, Nile Tilapia Fish Skin presented histomorphological similarities with human skin in pre-clinical studies. It was shown to have a deep dermis formed by thick collagen fibers organized on parallel/horizontal and transversal/vertical arrangement and composed, in comparison, by larger amounts of type I collagen. Nile Tilapia Fish Skin did not present variations in its microscopic structure and tensile strength after glycerolization, irradiation and posterior rehydration, recovering its natural consistency after glycerol removal.

DRUG

Silver Sulfadiazine Cream 1%

Topical antibiotic commonly used for the treatment of superficial and deep partial-thickness burns.

Trial Locations (2)

60025-061

Burn Treatment Center, Dr. José Frota Institute, Fortaleza

60430-275

Drug Research and Development Center (NPDM), Federal University of Ceará (UFC), Fortaleza

All Listed Sponsors
lead

Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara

OTHER

NCT04202289 - Use of Nile Tilapia Fish Skin as a Xenograft for Burn Treatment: Phase III Study | Biotech Hunter | Biotech Hunter