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

NCT ID: NCT04391582

Last Updated: 2020-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-04-12

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test - Tilapia Skin

After cleaning the lesion with tap water and 2% chlorhexidine gluconate, the tilapia skin was applied and covered with gauze and bandage.

Group Type: EXPERIMENTAL

Tilapia skin

Intervention Type: OTHER

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

Control - Silver sulfadiazine

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 band

Group Type: ACTIVE_COMPARATOR

silver sulfadiazine cream 1%

Intervention Type: DRUG

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

Interventions

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

Intervention Type: OTHER

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Children between the ages of 2 and 12 years admitted to our institution with superficial partial thickness burns less than 72 hours from the thermal injury

Exclusion Criteria

• Patients were excluded for a burn greater than 15% total body surface area (TBSA);
• Presence of a previous treatment for the current burn;
• Presence of a chemical or electrical burn;
• Presence of other significant diseases that could impact the volunteer's participation in the study;
• Presence of hypersensitivity to materials used in the study or to related compounds.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Edmar Maciel Lima Júnior

Plastic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Burn Treatment Center, Dr. José Frota Institute

Fortaleza, Ceará, Brazil

Countries

Brazil

Other Identifiers

Pediatric Burn Tilapia Skin

Identifier Type: -

Identifier Source: org_study_id