Use of Nile Tilapia Fish Skin as a Xenograft for Burn Treatment: Phase III Study

NCT ID: NCT04202289

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-03
• Study Completion Date: 2018-10-24

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.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Silver Sulfadiazine Cream 1%

In the control group, 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. The dressing changes occurred every 48 hours. The patients were evaluated every 48 hours for the study parameters.

Group Type: ACTIVE_COMPARATOR

Silver Sulfadiazine Cream 1%

Intervention Type: DRUG

Topical antibiotic commonly used for the treatment of superficial and deep partial-thickness burns.

Nile Tilapia Fish Skin

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 thrice in sterile 0.9% saline for 5 minutes, in order to remove glycerol. Regarding application in the study patients, after cleaning the lesion with tap water and 2% chlorhexidine gluconate, Nile Tilapia Fish Skin was applied and covered with gauze and bandage. Throughout the treatment, dressings with Nile Tilapia Fish Skin were only changed if the biomaterial was not properly adhered to the wound bed. The patients were evaluated every 48 hours for the study parameters.

Group Type: EXPERIMENTAL

Nile Tilapia Fish Skin

Intervention Type: DEVICE

In the search of new therapies for burns, the skin of Brazil's most cultivated fish, the Nile tilapia, which was mostly a waste product (although sometimes used as a resistant material for artisanal handicraft), was suggested as a possibility for the development of a low-cost xenograft. Apart from non-infectious microbiota, Nile Tilapia Fish Skin presented histomorphological similarities with human skin in pre-clinical studies. It was shown to have a deep dermis formed by thick collagen fibers organized on parallel/horizontal and transversal/vertical arrangement and composed, in comparison, by larger amounts of type I collagen. Nile Tilapia Fish Skin did not present variations in its microscopic structure and tensile strength after glycerolization, irradiation and posterior rehydration, recovering its natural consistency after glycerol removal.

Interventions

Nile Tilapia Fish Skin

In the search of new therapies for burns, the skin of Brazil's most cultivated fish, the Nile tilapia, which was mostly a waste product (although sometimes used as a resistant material for artisanal handicraft), was suggested as a possibility for the development of a low-cost xenograft. Apart from non-infectious microbiota, Nile Tilapia Fish Skin presented histomorphological similarities with human skin in pre-clinical studies. It was shown to have a deep dermis formed by thick collagen fibers organized on parallel/horizontal and transversal/vertical arrangement and composed, in comparison, by larger amounts of type I collagen. Nile Tilapia Fish Skin did not present variations in its microscopic structure and tensile strength after glycerolization, irradiation and posterior rehydration, recovering its natural consistency after glycerol removal.

Intervention Type: DEVICE

Silver Sulfadiazine Cream 1%

Topical antibiotic commonly used for the treatment of superficial and deep partial-thickness burns.

Intervention Type: DRUG

Other Intervention Names

Tilapia Skin; Silver Sulfadiazine

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara

OTHER

Sponsor Role: lead

Responsible Party

Edmar Maciel Lima Júnior

MD, Plastic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Elisabete A de Moraes, MD, PhD

Role: STUDY_DIRECTOR

Drug Research and Development Center (NPDM)

Locations

Burn Treatment Center, Dr. José Frota Institute

Fortaleza, Ceará, Brazil

Drug Research and Development Center (NPDM), Federal University of Ceará (UFC)

Fortaleza, Ceará, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 31214319 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31112268 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31504615 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29380095 (View on PubMed)

Related Links

https://clinicaltrials.gov/ct2/show/NCT03592498

Register on ClinicalTrials.gov of the Phase II Randomized Controlled Trial evaluating the use of Tilapia Skin in the treatment of burn wounds.

Other Identifiers

Nile Tilapia Fish Skin

Identifier Type: -

Identifier Source: org_study_id