Clinical trial NCT03592498: Study to Evaluate the Use of Tilapia Skin (Oreochromis Niloticus), in the Treatment of Burn Wounds
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Burns
Keywords: Burns
Wounds and Injuries
Biocompatible Materials
Nile Tilapia
Oreochromis niloticus.
Lead sponsor: Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical study Phase II, pilot, open, monocentric and randomized.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of days for complete re-epithelization in study A and B
timeFrame: Day 11
measure: Number of days for complete re-epithelization in study C
timeFrame: Day 21
measure: The number of dressings performed as needed in study A and B
timeFrame: Day 11
measure: The number of dressings performed as needed in study C
timeFrame: Day 21
measure: Amount of anesthetics or analgesics used throughout the treatment in study A and B
timeFrame: Day 11
measure: Amount of anesthetics or analgesics used throughout the treatment in study C
timeFrame: Day 21
Secondary outcomes:
measure: Change in scale of pain by the Visual Analogue Scale
timeFrame: 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).
measure: Change in Global Clinical Impression Scale - Disease Severity (CGI-S) scores
timeFrame: 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).
measure: Change in Global Clinical Impression Scale - Disease Improvement (CGI-I) scores
timeFrame: 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).
measure: Change in patient global assessment scores
timeFrame: 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).
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceara (UFC)
name: Maria Elisabete A Moraes, MD
role: STUDY_DIRECTOR
References:
citation: Alves APNN, Lima Junior EM, Piccolo NS, de Miranda MJB, Lima Verde MEQ, Ferreira Junior AEC, de Barros Silva PG, Feitosa VP, de Bandeira TJPG, Mathor MB, de Moraes MO. Study of tensiometric properties, microbiological and collagen content in nile tilapia skin submitted to different sterilization methods. Cell Tissue Bank. 2018 Sep;19(3):373-382. doi: 10.1007/s10561-017-9681-y. Epub 2018 Jan 29.
citation: Lima Junior EM, De Moraes Filho MO, Costa BA, Rohleder AVP, Sales Rocha MB, Fechine FV, Forte AJ, Alves APNN, Silva Junior FR, Martins CB, Mathor MB, Moraes MEA. Innovative Burn Treatment Using Tilapia Skin as a Xenograft: A Phase II Randomized Controlled Trial. J Burn Care Res. 2020 May 2;41(3):585-592. doi: 10.1093/jbcr/irz205.