NCT03592498

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

Randomised Clinical Study to Evaluate the Use of Tilapia Skin (Oreochromis Niloticus), as an Occlusive Biological Dressing, in the Treatment of Burn Wounds

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Burns

Interventions

Type	Name	Description
DRUG	Sulfadiazine, Silver	Application of silver sulfadiazine ointment, bandage covered with gauze and bandage.
DEVICE	Skin of Nile tilapia	Application of skin of Nile tilapia (Oreochromis niloticus), as a biological occlusive dressing.

Timeline

• Start date: 2016-10-05
• Primary completion: 2017-09-20
• Completion: 2017-09-20
• First posted: 2018-07-19
• Last updated: 2018-07-19