NCT04391582

Pediatric Burn Treatment Using Tilapia Skin as a Xenograft for Superficial-Partial Thickness Wounds

Pediatric Burn Treatment Using Tilapia Skin as a Xenograft for Superficial-Partial Thickness Wounds: a Randomized Controlled Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara · Academic / Other
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy of Nile tilapia skin as a xenograft for the treatment of partial-thickness burn wounds in children.

Detailed description

This is an open-label, monocentric, randomized phase II pilot study conducted in Fortaleza, Brazil. The study population consisted of 30 children between the ages of 2 and 12 years with superficial "partial-thickness" burns admitted less than 72 hours from the thermal injury. In the test group, the tilapia skin was applied. In the control group, a thin layer of silver sulfadiazine cream 1% was applied.

Conditions

• Burns

Interventions

Type	Name	Description
OTHER	Tilapia skin	After cleaning the lesion with tap water and 2% chlorhexidine gluconate, the tilapia skin was applied and covered with gauze and bandage. These dressings were changed only if the tilapia skin did not adhere properly to the wound bed
DRUG	silver sulfadiazine cream 1%	After cleaning the lesion with tap water and 2% chlorhexidine gluconate, a thin layer of silver sulfadiazine cream 1% was applied and covered with gauze and bandage. In these patients, the dressings were changed daily

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-04-12
• Completion: 2018-04-12
• First posted: 2020-05-18
• Last updated: 2020-05-18

Locations

1 site across 1 country: Brazil