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

• Status: Completed
• Trial end date: 2018-10-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
• Treatments: Silver Sulfadiazine; Sulfadiazine

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.