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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Burns

Intervention / Treatment
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* Other: Tilapia skin
* Drug: silver sulfadiazine cream 1%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This was an open-label, monocentric, randomized phase II clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test - Tilapia Skin<br>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<br>* 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<br>|
| Active Comparator: Control - Silver sulfadiazine<br>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%<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burns, Wounds and Injuries, Biocompatible Materials, Nile Tilapia, Oreochromis niloticus