Use of Nile Tilapia Fish Skin as a Xenograft for Burn Treatment: Phase III Study
Condition: Burns
MeSH terms: Burns
Study type: Interventional
Phase: Phase 3

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.
    

Detailed 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.
    

Intervention name(s): Nile Tilapia Fish Skin; Silver Sulfadiazine Cream 1%
Intervention type(s): Device; Drug
Intervention description(s): 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.; Topical antibiotic commonly used for the treatment of superficial and deep partial-thickness burns.
Other intervention name(s): Tilapia Skin; Silver Sulfadiazine
Intervention MeSH terms: Sulfadiazine; Silver Sulfadiazine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, monocentric, open-label, controlled phase III clinical study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Burns; Nile tilapia; Xenograft; Oreochromis niloticus; Biocompatible materials; Wound healing