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

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ClinicalTrials.gov Identifier: NCT03592498
Recruitment Status : Completed
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Edmar Maciel Lima Júnior, Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Burns Drug: Sulfadiazine, Silver Device: Skin of Nile tilapia Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Clinical study Phase II, pilot, open, monocentric and randomized.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Clinical Study to Evaluate the Use of Tilapia Skin (Oreochromis Niloticus), as an Occlusive Biological Dressing, in the Treatment of Burn Wounds
Actual Study Start Date : October 5, 2016
Actual Primary Completion Date : September 20, 2017
Actual Study Completion Date : September 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sulfadiazine, Silver
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
Application of silver sulfadiazine ointment, bandage covered with gauze and bandage.

Experimental: Skin of Nile tilapia

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
Application of skin of Nile tilapia (Oreochromis niloticus), as a biological occlusive dressing.




Primary Outcome Measures :
  1. Number of days for complete re-epithelization in study A and B [ Time Frame: Day 11 ]
    Number of days until complete re-epithelialization observed by the evaluator

  2. Number of days for complete re-epithelization in study C [ Time Frame: Day 21 ]
    Number of days until complete re-epithelialization observed by the evaluator

  3. The number of dressings performed as needed in study A and B [ Time Frame: Day 11 ]
    Relation to the number of dressings performed in patients treated with Silver Sulfadiazine and Tilapia Skin throughout the treatment.

  4. The number of dressings performed as needed in study C [ Time Frame: Day 21 ]
    Relation to the number of dressings performed in patients treated with Silver Sulfadiazine and Tilapia Skin throughout the treatment.

  5. Amount of anesthetics or analgesics used throughout the treatment in study A and B [ Time Frame: Day 11 ]
    Use of anesthetics or analgesics required for the change of dressings performed throughout the treatment.

  6. Amount of anesthetics or analgesics used throughout the treatment in study C [ Time Frame: Day 21 ]
    Use of anesthetics or analgesics required for the change of dressings performed throughout the treatment.


Secondary Outcome Measures :
  1. Change in scale of pain by the Visual Analogue Scale [ Time Frame: 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). ]
    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.

  2. Change in Global Clinical Impression Scale - Disease Severity (CGI-S) scores [ Time Frame: 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). ]
    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.

  3. Change in Global Clinical Impression Scale - Disease Improvement (CGI-I) scores [ Time Frame: 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). ]
    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.

  4. Change in patient global assessment scores [ Time Frame: 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). ]
    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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592498


Sponsors and Collaborators
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
Investigators
Study Director: Maria Elisabete A Moraes, MD Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceara (UFC)

Additional Information:
Publications:
Responsible Party: Edmar Maciel Lima Júnior, MD, Plastic Surgeon, Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
ClinicalTrials.gov Identifier: NCT03592498     History of Changes
Other Study ID Numbers: Pele de tilápia
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Edmar Maciel Lima Júnior, Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara:
Burns
Wounds and Injuries
Biocompatible Materials
Nile Tilapia
Oreochromis niloticus.

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Sulfadiazine
Silver Sulfadiazine
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Anti-Infective Agents, Local