Clinical trial NCT04202289: Use of Nile Tilapia Fish Skin as a Xenograft for Burn Treatment: Phase III Study
Official title: Evaluation of Nile Tilapia (Oreochromis Niloticus) Skin as an Occlusive Biological Dressing in the Treatment of Burn Wounds: Phase III Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Burns
Keywords: Burns
Nile tilapia
Xenograft
Oreochromis niloticus
Biocompatible materials
Wound healing
Lead sponsor: Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, monocentric, open-label, controlled phase III clinical study
Primary purpose: TREATMENT

Brief summary: The present study is a Phase III Randomized Clinical Trial aiming to evaluate the efficacy of Nile tilapia (Oreochromis niloticus) skin as an occlusive biological dressing in the treatment of superficial partial-thickness burns in adults.

Detailed description: This is a prospective, randomized, monocentric, open-label, controlled phase III clinical study conducted in Fortaleza, Brazil, from April 2017 to October 2018. The local Institutional Review Board approved the study protocol and informed consent, which was obtained from all participants. The research was conducted in accordance with the 1975 Declaration of Helsinki and its amendments.

The study population consisted of 115, both male and female, participants, who were recruited from a local burn treatment center. Inclusion criteria were: age ≥ 18 and ≤60 years; the presence of dermatological wounds caused by superficial partial-thickness burns (SPTB) affecting up to 15% of Total Body Surface Area (TBSA) and with indication for outpatient treatment; the absence of previous treatment for the current burn and an absence of other significant diseases that could impact the volunteer's participation in the study (coronary artery disease, peripheral vascular disease, cancer, diabetes mellitus, among others). Exclusion criteria included hypersensitivity to materials used in the study or to related compounds; history of severe adverse reactions; drug addiction, including alcohol; use of medications that could have an impact on wound healing (e.g., steroids) and pregnancy, labor or miscarriage in the 12 weeks before the scheduled start of treatment.

In the test group, the treatment was Nile Tilapia Fish Skin, which have a patent registered at the National Institute of Industrial Property (INPI) under number BR 10 2015 021435 9. Nile Tilapia Fish Skin was subjected to a rigorous process of chemical sterilization, glycerolization and irradiation, followed by microbiological tests for bacteria and fungi, before storage in sterile refrigerated packaging. Prior to its use in the patient, the skin was washed in sterile 0.9% saline for 5 minutes, with this process being repeated three times in a row. In the control group, conventional treatment with silver sulfadiazine cream 1% was applied. Randomization was performed using a predefined computer-generated list, with 57 patients being allocated in the test group and 58 patients being allocated in the control group.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 and ≤60 years.
* Presence of dermatological wounds caused by superficial partial-thickness burns (SPTB) affecting up to 15% of Total Body Surface Area (TBSA).
* Patient with indication for outpatient treatment.

Exclusion Criteria:

* Previous treatment for the current burn.
* Presence of other significant diseases that could impact the volunteer's participation in the study (coronary artery disease, peripheral vascular disease, cancer, diabetes mellitus, among others).
* Hypersensitivity to materials used in the study or to related compounds.
* History of severe adverse reactions; drug addiction, including alcohol.
* Use of medications that could have an impact on wound healing (e.g., steroids).
* Pregnancy, labor or miscarriage in the 12 weeks before the scheduled start of treatment.

Primary outcomes:
measure: Number of days for complete reepithelialization of the burn wound
timeFrame: Day 11
measure: Number of dressings performed
timeFrame: Day 11
measure: Amount of anesthetics used throughout the treatment
timeFrame: Day 11
measure: Treatment cost per patient
timeFrame: Day 11
Secondary outcomes:
measure: Pain intensity evaluation via Visual Analogue Scale scores
timeFrame: Day 1, 3, 5, 7, 9 and 11
measure: Pain intensity evaluation via Electronic von Frey
timeFrame: Day 1, 3, 5, 7, 9 and 11
measure: Burns Specific Pain Anxiety Scale (BSPAS) scores
timeFrame: Day 5 and 11
measure: Burn improvement on the day of dressing removal evaluation
timeFrame: Day 11
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Burn Treatment Center, Dr. José Frota Institute
state: Ceará
city: Fortaleza
country: Brazil
facility: Drug Research and Development Center (NPDM), Federal University of Ceará (UFC)
state: Ceará
Study officials:
affiliation: Drug Research and Development Center (NPDM)
name: Maria Elisabete A de Moraes, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Lima-Junior EM, de Moraes Filho MO, Costa BA, Fechine FV, de Moraes MEA, Silva-Junior FR, Soares MFADN, Rocha MBS, Leontsinis CMP. Innovative treatment using tilapia skin as a xenograft for partial thickness burns after a gunpowder explosion. J Surg Case Rep. 2019 Jun 14;2019(6):rjz181. doi: 10.1093/jscr/rjz181. eCollection 2019 Jun.
citation: Costa BA, Lima Junior EM, de Moraes Filho MO, Fechine FV, de Moraes MEA, Silva Junior FR, do Nascimento Soares MFA, Rocha MBS. Use of Tilapia Skin as a Xenograft for Pediatric Burn Treatment: A Case Report. J Burn Care Res. 2019 Aug 14;40(5):714-717. doi: 10.1093/jbcr/irz085.
citation: Lima Junior EM, Moraes Filho MO, Forte AJ, Costa BA, Fechine FV, Alves APNN, Moraes MEA, Rocha MBS, Silva Junior FR, Soares MFADN, Bezerra AN, Martins CB, Mathor MB. Pediatric Burn Treatment Using Tilapia Skin as a Xenograft for Superficial Partial-Thickness Wounds: A Pilot Study. J Burn Care Res. 2020 Feb 19;41(2):241-247. doi: 10.1093/jbcr/irz149.
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.