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

Sponsor

Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara (Other)

Overall Status

Completed

CT.gov ID

NCT04391582

Collaborator

(none)

Enrollment

Location

Arms

11.4

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burns	Other: Tilapia skin Drug: silver sulfadiazine cream 1%	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2017

Actual Primary Completion Date :

Apr 12, 2018

Actual Study Completion Date :

Apr 12, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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
Active Comparator: 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	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

Arm

Intervention/Treatment

Experimental: 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.

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

Active Comparator: 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

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

Outcome Measures

Primary Outcome Measures

Complete burn wound healing [Day 11]
The number of days to complete burn wound healing (≥95% reepithelialization), calculated via clinical judgment from the consultant.
Assessment of pain via the Faces Pain Scale-Revised (FPS-R). [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.
Assessment of pain via CONFORT-B scale. [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.
Assessment of pain via FLACCr scale. [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 Outcome Measures

Number of dressings performed. [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.
Total amount of anesthetics and analgesics required throughout the treatment [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
Evaluation of burn improvement via the Clinical Global Impression Scale-Improvement (CGI-I). [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"
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]
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."

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 12 Years

Sexes Eligible for Study:

All

Accepts 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.