Study to Evaluate the Use of Tilapia Skin (Oreochromis Niloticus), in the Treatment of Burn Wounds

Study Overview
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Brief Summary
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Randomised Clinical Study to evaluate the efficacy of Nile tilapia (Oreochromis niloticus) skin as an occlusive biological dressing, in the treatment of humans burn wounds.

Detailed Description
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This was a randomized, monocentric; open-label pilot clinical study conducted at the Dr. José Frota Institute's Burn Treatment Center, located in Fortaleza, Ceará, Brazil, from October 2016 to September 2017. The study participants were recruited from the population of patients attending the Burning Treatment Center of the Dr. José Frota Institute. Were included female and male participants, age range greater than or equal to 18 and greater than or equal to 50 years old and who met the following criteria: presence of a dermatological wound caused by superficial second-degree burn with up to 20% of the body surface or deep second degree with area of 5 to 15% of the body surface; absence of previous treatment for the current burn and without other significant diseases that could impact their participation in the study. No study participants were known to have hypersensitivity to materials used in the study or to related compounds; history of serious adverse reactions; addiction to drugs, including alcohol; pregnancy and labor or miscarriage in the 12 weeks prior to the scheduled start of treatment. The study was divided according to the depth and burned body surface area of the research participant: Study A: Burning of 2nd Surface Degree with <10% of body surface area - Patients in outpatient care, within this group, the research participants were randomly assigned to the following treatment groups: active comparator (sulfadiazine, Silver) or experimental (skin of Nile tilapia). Study B: 2nd Degree Burn with 10 to 20% body surface area - Inpatient, within this group, the research participants were randomly assigned to the following treatment groups: active comparator (sulfadiazine, Silver) or experimental (skin of Nile tilapia). Study C: Deep 2nd Degree Burn with 5 to 15% body surface area - Inpatient, within this group, the research participants were randomly assigned to the following treatment groups: active comparator (sulfadiazine, Silver) or experimental (skin of Nile tilapia). Interventions: Participants were randomly assigned to the following treatments: Experimental intervention: use of the skin of Nile tilapia (Oreochromis niloticus), as a biological occlusive dressing; Active comparator intervention: Conventional treatment with silver sulfadiazine.

Official Title
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Randomised Clinical Study to Evaluate the Use of Tilapia Skin (Oreochromis Niloticus), as an Occlusive Biological Dressing, in the Treatment of Burn Wounds

Conditions
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Burns

Intervention / Treatment
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* Drug: Sulfadiazine, Silver
* Device: Skin of Nile tilapia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of a dermatological wound caused by superficial second-degree burn with up to 20% of the body surface or deep second degree with area of 5 to 15% of the body surface; Absence of previous treatment for the current burn Without other significant diseases that could impact their participation in the study Exclusion Criteria: Hypersensitivity to materials used in the study or to related compounds; History of serious adverse reactions; Addiction to drugs, including alcohol; Pregnancy Labor or miscarriage in the 12 weeks prior to the scheduled start of treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Clinical study Phase II, pilot, open, monocentric and randomized.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sulfadiazine, Silver<br>Intervention: Treatment with silver sulfadiazine ointment. Procedures: wound washing, application of silver sulfadiazine ointment, bandage covered with gauze and bandage. These patients undergone the change of dressings on alternate days. | Drug: Sulfadiazine, Silver<br>* Application of silver sulfadiazine ointment, bandage covered with gauze and bandage.<br>|
| Experimental: Skin of Nile tilapia<br>Intervention: treatment with skin of Nile tilapia (Oreochromis niloticus), as a biological occlusive dressing. Procedures: wound washing, application of tilapia skin and dressing with gauze and bandage. These dressings were changed if the skin of the tilapia was loose (not adhered). | Device: Skin of Nile tilapia<br>* Application of skin of Nile tilapia (Oreochromis niloticus), as a biological occlusive dressing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days for complete re-epithelization in study A and B | Number of days until complete re-epithelialization observed by the evaluator | Day 11 | 
| Number of days for complete re-epithelization in study C | Number of days until complete re-epithelialization observed by the evaluator | Day 21 | 
| The number of dressings performed as needed in study A and B | Relation to the number of dressings performed in patients treated with Silver Sulfadiazine and Tilapia Skin throughout the treatment. | Day 11 | 
| The number of dressings performed as needed in study C | Relation to the number of dressings performed in patients treated with Silver Sulfadiazine and Tilapia Skin throughout the treatment. | Day 21 | 
| Amount of anesthetics or analgesics used throughout the treatment in study A and B | Use of anesthetics or analgesics required for the change of dressings performed throughout the treatment. | Day 11 | 
| Amount of anesthetics or analgesics used throughout the treatment in study C | Use of anesthetics or analgesics required for the change of dressings performed throughout the treatment. | Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scale of pain by the Visual Analogue Scale | The visual Analogue scale consists of assisting in the assessment of pain intensity in the patient, being an important instrument to verify the evolution of the patient during the treatment. In each visit, the patient was instructed to respond as he rated his pain through scores ranging 0 to 10, where 0 to 2 meant mild pain, 3 to 7 meant moderate pain and 8 to 10 meant severe pain. | Day 1, 3, 5, 7, 9, 11, 15 and 30 (group A and B) and day 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25 and 40 (group C). | 
| Change in Global Clinical Impression Scale - Disease Severity (CGI-S) scores | The evaluation of change in the scores of burn severity was performed by the physician during the study, using the global clinical impression scale - disease severity, which consistes of answering the following question - Considering your experience with this type of problem, what is the degree of severity of this patient's illness at the moment?? - Where, 0 means not evaluated, 1 - Much better, 2 - moderately better, 3 - Slightly better, 4 - unchanged, 5 - Slightly worse, 6 - Moderately worse and 7 - Much worse. | Day 1, 3, 5, 7, 9, 11, 15 and 30 (group A and B) and day 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25 and 40 (group C). | 
| Change in Global Clinical Impression Scale - Disease Improvement (CGI-I) scores | The evaluation of change in the scores of burn improvement was performed by the physician during the study, using the global clinical impression scale - disease improvement, which consists of answering the following question - Compared to the initial state, how is the patient at this time? - Where, 0 means Not evaluated, 1 - Much better, 2 - moderately better, 3 - Slightly better, 4 - unchanged, 5 - Slightly worse, 6 - Moderately worse and 7 - Much worse. | Day 1, 3, 5, 7, 9, 11, 15 and 30 (group A and B) and day 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25 and 40 (group C). | 
| Change in patient global assessment scores | The change in the patient burn-related symptoms was realized by answering the following question: Compared to the initial state, how is your disease-related symptoms at this time? - Where, 0 means much better, 1 - moderately better, 2 - Slightly better, 3 - unchanged, 4 - Slightly worse, 5 - Moderately worse and 6 - Much worse. | Day 1, 3, 5, 7, 9, 11, 15 and 30 (group A and B) and day 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25 and 40 (group C). | 

 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.