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

NCT04202289 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2020-01-29

No results posted yet for this study

Summary

The present study is a Phase III Randomized Clinical Trial aiming to evaluate the efficacy of Nile tilapia (Oreochromis niloticus) skin as an occlusive biological dressing in the treatment of superficial partial-thickness burns in adults.

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Maria Elisabete A de Moraes, MD, PhD · Drug Research and Development Center (NPDM)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-03
Primary Completion
2018-10-24
Completion
2018-10-24

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04202289 on ClinicalTrials.gov