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

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

Status and phase: Completed; Phase 2

Conditions: Burns

Treatments: Drug: silver sulfadiazine cream 1%; Other: Tilapia skin

Study type: Interventional

Funder types: Other

Identifiers

NCT04391582

Pediatric Burn Tilapia Skin

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Test - Tilapia Skin

Experimental group

Description:

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

Treatment:

Other: Tilapia skin

Control - Silver sulfadiazine

Active Comparator group

Description:

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

Treatment:

Drug: silver sulfadiazine cream 1%