Back to resultsPediatric Burn Treatment Using Tilapia Skin as a Xenograft for Superficial-Partial Thickness Wounds
Primary Purpose
Burns
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Tilapia skin
silver sulfadiazine cream 1%
Sponsored by
About this trial
This is an interventional treatment trial for Burns focused on measuring Burns, Wounds and Injuries, Biocompatible Materials, Nile Tilapia, Oreochromis niloticus
Eligibility Criteria
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.
Sites / Locations
- Burn Treatment Center, Dr. José Frota Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test - Tilapia Skin
Control - Silver sulfadiazine
Arm Description
After cleaning the lesion with tap water and 2% chlorhexidine gluconate, the tilapia skin was applied and covered with gauze and bandage.
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
Outcomes
Primary Outcome Measures
Complete burn wound healing
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).
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.
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.
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.
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
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).
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).
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."
Full Information
NCT ID
NCT04391582
First Posted
April 30, 2020
Last Updated
May 12, 2020
Sponsor
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
1. Study Identification
Unique Protocol Identification Number
NCT04391582
Brief Title
Pediatric Burn Treatment Using Tilapia Skin as a Xenograft for Superficial-Partial Thickness Wounds
Official Title
Pediatric Burn Treatment Using Tilapia Skin as a Xenograft for Superficial-Partial Thickness Wounds: a Randomized Controlled Phase II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
April 12, 2018 (Actual)
Study Completion Date
April 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Burns, Wounds and Injuries, Biocompatible Materials, Nile Tilapia, Oreochromis niloticus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This was an open-label, monocentric, randomized phase II clinical trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test - Tilapia Skin
Arm Type
Experimental
Arm Description
After cleaning the lesion with tap water and 2% chlorhexidine gluconate, the tilapia skin was applied and covered with gauze and bandage.
Arm Title
Control - Silver sulfadiazine
Arm Type
Active Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
Tilapia skin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
silver sulfadiazine cream 1%
Intervention 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 bandage. In these patients, the dressings were changed daily
Primary Outcome Measure Information:
Title
Complete burn wound healing
Description
The number of days to complete burn wound healing (≥95% reepithelialization), calculated via clinical judgment from the consultant.
Time Frame
Day 11
Title
Assessment of pain via the Faces Pain Scale-Revised (FPS-R).
Description
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.
Time Frame
Day 11
Title
Assessment of pain via CONFORT-B scale.
Description
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.
Time Frame
Day 11
Title
Assessment of pain via FLACCr scale.
Description
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).
Time Frame
Day 11
Secondary Outcome Measure Information:
Title
Number of dressings performed.
Description
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.
Time Frame
Day 11
Title
Total amount of anesthetics and analgesics required throughout the treatment
Description
To audit anesthetics and analgesics intake, nurses were trained to register on the patient's clinical record all analgesic and anesthetic medications used
Time Frame
Day 11
Title
Evaluation of burn improvement via the Clinical Global Impression Scale-Improvement (CGI-I).
Description
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"
Time Frame
Day 3, day 5, day 7, day 9 and day 11
Title
Evaluation of burn severity via the Clinical Global Impression Scale- Severity (CGI-S).
Description
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."
Time Frame
Day 1, day 3, day 5, day 7, day 9 and day 11
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Burn Treatment Center, Dr. José Frota Institute
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60025-061
Country
Brazil
12. IPD Sharing Statement
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Pediatric Burn Treatment Using Tilapia Skin as a Xenograft for Superficial-Partial Thickness Wounds
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