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

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

Status and phase: Completed; Phase 3

Conditions: Burns

Treatments: Drug: Silver Sulfadiazine Cream 1%; Device: Nile Tilapia Fish Skin

Study type: Interventional

Funder types: Other

Identifiers

NCT04202289

Nile Tilapia Fish Skin

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 2 patient groups

Silver Sulfadiazine Cream 1%

Active Comparator group

Description:

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.

Treatment:

Drug: Silver Sulfadiazine Cream 1%

Nile Tilapia Fish Skin

Experimental group

Description:

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.

Treatment:

Device: Nile Tilapia Fish Skin