The aim of this study is validate the use of biopolymer from sugar cane molasses film (POLYSHAFT®) a product developed in Experimental Station research laboratories (UFRPE) comparing to polyurethane film, or similar, used as a bandage after surgical correction of hypospadias, as well as other procedures. The main objective of the study is to prove the hypothesis the POLYSHAFT® presents similar or better outcomes in terms of biocompatibility, when compared to the polyurethane film when used as a bandage.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months