Study to Evaluate the Use of Tilapia Skin (Oreochromis Niloticus), in the Treatment of Burn Wounds

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-05

Study Completion Date

2017-09-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04202289

Burns

COMPLETED PHASE3

Pediatric Burn Treatment Using Tilapia Skin as a Xenograft for Superficial-Partial Thickness Wounds

NCT04391582

Burns

COMPLETED PHASE2

Comparison Between Burn Dressing Using Tilapia-Fish Skin Versus Regular Dressing

NCT07142824

Burns

RECRUITING NA

Burn Coverage of Burn by Tilapia Fish Skin

NCT06549569

Tilapia Fish Skin in Burn Coverage

COMPLETED

A Randomized Trial Evaluating EARLY Application of a Surfactant Dressing in Thermal Injury (EARLY)

NCT04880655

Burns Partial-thickness Burn

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Burns

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Clinical study Phase II, pilot, open, monocentric and randomized.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sulfadiazine, Silver

Intervention: Treatment with silver sulfadiazine ointment. Procedures: wound washing, application of silver sulfadiazine ointment, bandage covered with gauze and bandage. These patients undergone the change of dressings on alternate days.

Group Type ACTIVE_COMPARATOR

Sulfadiazine, Silver

Intervention Type DRUG

Application of silver sulfadiazine ointment, bandage covered with gauze and bandage.

Skin of Nile tilapia

Intervention: treatment with skin of Nile tilapia (Oreochromis niloticus), as a biological occlusive dressing.

Procedures: wound washing, application of tilapia skin and dressing with gauze and bandage. These dressings were changed if the skin of the tilapia was loose (not adhered).

Group Type EXPERIMENTAL

Skin of Nile tilapia

Intervention Type DEVICE

Application of skin of Nile tilapia (Oreochromis niloticus), as a biological occlusive dressing.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sulfadiazine, Silver

Application of silver sulfadiazine ointment, bandage covered with gauze and bandage.

Intervention Type DRUG

Skin of Nile tilapia

Application of skin of Nile tilapia (Oreochromis niloticus), as a biological occlusive dressing.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No