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

NCT04391582 | Completed Phase 2

• 1 other identifier: Pediatric Burn Tilapia Skin
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

Burns; Wounds and Injuries; Biocompatible Materials; Nile Tilapia; Oreochromis niloticus

Outcome Measures

Primary Outcomes (4)

• Complete burn wound healing

  The number of days to complete burn wound healing (≥95% reepithelialization), calculated via clinical judgment from the consultant.

  Day 11

• Assessment of pain via the Faces Pain Scale-Revised (FPS-R).

  The pain evaluation via the FPS-R was performed by the patient himself or herself if aged 5 years or more, or by their caregiver in patients under 5 years of age. The scale consists of six faces, presented horizontally, that depict different degrees of pain, from "no pain" to "most pain possible". A numerical value from 0 to 10 is assigned to each face.

  Day 11

• Assessment of pain via CONFORT-B scale.

  The pain evaluation via CONFORT-B Scale was performed by the physician responsible and assessed the pain based in a behavioral that consisted in six factors: alertness, calmness/agitation, respiratory response (or crying), physical movement, muscle tone, and facial tension.Each factor was scored with values ranging between 1 and 5, generating scores between 6 and 30 points.

  Day 11

• Assessment of pain via FLACCr scale.

  The pain evaluation via FLACCr scale was performed by the physician responsible and answered five evaluation categories based on behavioral parameters with combined scores ranging from zero to ten (classified the scores as follows: zero to three (mild pain); four to six (moderate pain) and seven to ten (severe pain).

  Day 11

Secondary Outcomes (4)

• Number of dressings performed.

  Day 11

• Total amount of anesthetics and analgesics required throughout the treatment

  Day 11

• Evaluation of burn improvement via the Clinical Global Impression Scale-Improvement (CGI-I).

  Day 3, day 5, day 7, day 9 and day 11

• Evaluation of burn severity via the Clinical Global Impression Scale- Severity (CGI-S).

  Day 1, day 3, day 5, day 7, day 9 and day 11

Study Arms (2)

Test - Tilapia Skin

EXPERIMENTAL

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

Other: Tilapia skin

Control - Silver sulfadiazine

ACTIVE COMPARATOR

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

Drug: silver sulfadiazine cream 1%

Interventions

Tilapia skin 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

Test - Tilapia Skin

silver sulfadiazine cream 1% 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

Control - Silver sulfadiazine

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Burn Treatment Center, Dr. José Frota Institute

Fortaleza, Ceará, 60025-061, Brazil

Location

MeSH Terms

Conditions

Burns; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic Surgeon

Model Details: This was an open-label, monocentric, randomized phase II clinical trial.

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 18, 2020
• Study Start: May 1, 2017
• Primary Completion: April 12, 2018
• Study Completion: April 12, 2018
• Last Updated: May 18, 2020

Record last verified: 2020-05

Locations

BR (1)