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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04391582
• Other study ID #: Pediatric Burn Tilapia Skin
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2017
• Est. completion date: April 12, 2018

Study information

• Verified date: May 2020
• Source: Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 12, 2018
• Est. primary completion date: April 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

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

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

Locations

Country	Name	City	State
Brazil	Burn Treatment Center, Dr. José Frota Institute	Fortaleza	Ceará

Sponsors (1)

Lead Sponsor	Collaborator
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete burn wound healing	The number of days to complete burn wound healing (=95% reepithelialization), calculated via clinical judgment from the consultant.	Day 11
Primary	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
Primary	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
Primary	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	Number of dressings performed.	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.	Day 11
Secondary	Total amount of anesthetics and analgesics required throughout the treatment	To audit anesthetics and analgesics intake, nurses were trained to register on the patient's clinical record all analgesic and anesthetic medications used	Day 11
Secondary	Evaluation of burn improvement via the Clinical Global Impression Scale-Improvement (CGI-I).	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"	Day 3, day 5, day 7, day 9 and day 11
Secondary	Evaluation of burn severity via the Clinical Global Impression Scale- Severity (CGI-S).	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."	Day 1, day 3, day 5, day 7, day 9 and day 11