Skip to main content
OpenTrials
Completed

NCT Number: NCT04391582

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Burns Wounds and Injuries

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Burn Treatment Center, Dr. José Frota Institute

Fortaleza, Ceará, 60025-061, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Complete burn wound healing

    Time frame: Day 11

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

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

    Time frame: Day 11

    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.

  3. Assessment of pain via CONFORT-B scale.

    Time frame: Day 11

    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.

  4. Assessment of pain via FLACCr scale.

    Time frame: Day 11

    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).

Secondary outcomes

  1. Number of dressings performed.

    Time frame: Day 11

    In the test group, a dressing change was defined as the act of replacing the tilapia skin that did not adhere properly and/or replacing gauze and bandage that is full of exudate, after an evaluation of the dressing (performed every 48 hours). In the control group, a dressing change was defined as the daily act of cleaning the wound and reapplying the silver sulfadiazine cream 1%, which is then covered with new gauze and bandage.

  2. Total amount of anesthetics and analgesics required throughout the treatment

    Time frame: Day 11

    To audit anesthetics and analgesics intake, nurses were trained to register on the patient's clinical record all analgesic and anesthetic medications used

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

    Time frame: Day 3, day 5, day 7, day 9 and day 11

    The CGI-I was evaluated by the physician responsible and answers the following question: "Compared to the patient's condition at admission to the project, this patient's condition is: 1 - very much improved since the initiation of treatment; 2 - much improved; 3 - minimally improved; 4 - no change from baseline; 5 - minimally worse; 6 - much worse; 7 - very much worse since the initiation of treatment"

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

    Time frame: Day 1, day 3, day 5, day 7, day 9 and day 11

    The CGI-I was evaluated by the physician responsible and answers the following question: "Compared to the patient's condition at admission to the project, this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment."

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 18, 2020
Registry last updated
May 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.