Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information 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. In the control group, conventional treatment with silver sulfadiazine cream 1% was applied. 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. 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. 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. 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. 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). The study population consisted of 115, both male and female, participants, who were recruited from a local burn treatment center. The research was conducted in accordance with the 1975 Declaration of Helsinki and its amendments.
The local Institutional Review Board approved the study protocol and informed consent, which was obtained from all participants. This is a prospective, randomized, monocentric, open-label, controlled phase III clinical study conducted in Fortaleza, Brazil, from April 2017 to October 2018. Why Should I Register and Submit Results?.Vitamin A fact sheet for health professionals. National Institutes of Health Office of Dietary Supplements.
FISH SKIN FOR BURN VICTIMS TRIAL
Vitamin E and the risk of prostate cancer: the Selenium and Vitamin E Cancer Prevention Trial (SELECT).
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