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

NCT04202289 | Completed Phase 3

• 1 other identifier: Nile Tilapia Fish Skin
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 2

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.

Conditions

Burns

Keywords

Burns; Nile tilapia; Xenograft; Oreochromis niloticus; Biocompatible materials; Wound healing

Outcome Measures

Primary Outcomes (4)

• Number of days for complete reepithelialization of the burn wound

  Number of days until complete reepithelialization of the burn wound, considering application of the first dressing as day zero. Complete reepithelialization was defined as a ≥95% reepithelialization calculated via clinical judgment from the consultant

  Day 11

• Number of dressings performed

  In the control group, a dressing change was defined as the act of cleaning the wound and reapplying the Silver Sulfadiazine Cream 1%, which was performed every 48 hours. In the test group, a dressing change was defined as the act of replacing the Nile Tilapia Fish Skin which did not adhere properly and/or replacing gauze and bandage that is full of exudate.

  Day 11

• Amount of anesthetics used throughout the treatment

  In order to audit analgesic intake, apart from the medication prescription (dipyrone and/or tramadol), the patients received a daily record card. They were asked to take the medication only if they felt pain, always respecting instructions in the prescription, and to register the amount of medication taken and the date on the card. Upon returning for medical evaluation, the remaining medication was checked and compared to the daily record card.

  Day 11

• Treatment cost per patient

  Consumption of materials of the burn treatment center was controlled by the completion of a specific form, an activity performed at the end of each patient visit by the nursing staff. The resources consumed were divided into three categories: a) products used for wound management (either Nile Tilapia Fish Skin or Silver Sulfadiazine Cream 1%); (b) hospital material required for dressing preparation (such as sterile gloves, chlorhexidine, gauze, and bandage); and c) analgesic medication required throughout treatment (dipyrone and/or tramadol). Human resources were not evaluated.

  Day 11

Secondary Outcomes (4)

• Pain intensity evaluation via Visual Analogue Scale scores

  Day 1, 3, 5, 7, 9 and 11

• Pain intensity evaluation via Electronic von Frey

  Day 1, 3, 5, 7, 9 and 11

• Burns Specific Pain Anxiety Scale (BSPAS) scores

  Day 5 and 11

• Burn improvement on the day of dressing removal evaluation

  Day 11

Study Arms (2)

Silver Sulfadiazine Cream 1%

ACTIVE COMPARATOR

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.

Drug: Silver Sulfadiazine Cream 1%

Nile Tilapia Fish Skin

EXPERIMENTAL

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.

Device: Nile Tilapia Fish Skin

Interventions

Nile Tilapia Fish Skin 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.

Also known as: Tilapia Skin

Nile Tilapia Fish Skin

Silver Sulfadiazine Cream 1% DRUG

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

Also known as: Silver Sulfadiazine

Silver Sulfadiazine Cream 1%

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara: lead

Study Sites (2)

Burn Treatment Center, Dr. José Frota Institute

Fortaleza, Ceará, 60025-061, Brazil

Location

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

Fortaleza, Ceará, 60430-275, Brazil

Location

Related Publications (4)

• 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.

  PMID: 31214319 BACKGROUND

• 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.

  PMID: 31112268 BACKGROUND

• 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.

  PMID: 31504615 BACKGROUND

• 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.

  PMID: 29380095 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Burns

Interventions

Silver Sulfadiazine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Sulfadiazine; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Maria Elisabete A de Moraes, MD, PhD

  Drug Research and Development Center (NPDM)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients were blinded to the hypothesized effects of either treatment, but neither the patients nor the consultant were blinded to the treatment administered, due to the necessity of visualizing the treatments in order to conduct them properly (i.e., both types of dressing need to be seen to be applied, evaluated, replaced and removed adequately).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Plastic Surgeon

Model Details: Prospective, randomized, monocentric, open-label, controlled phase III clinical study

Study Record Dates

• First Submitted: December 14, 2019
• First Posted: December 17, 2019
• Study Start: April 3, 2017
• Primary Completion: October 24, 2018
• Study Completion: October 24, 2018
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)