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Study Comparing the Polyurethane Films and Sugarcane Biopolymer Used as Dressings

NCT02531828 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2015-08-25

No results posted yet for this study

Summary

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.

Conditions

  • Wound
  • Rupture
  • Surgery
  • Cesarean Section

Interventions

DEVICE

Application of dressings for surgical correction.

Dressing for surgical correction

DEVICE

POLYSHAFT®

Sponsors & Collaborators

  • Universidade Federal de Pernambuco

    collaborator OTHER

  • Rio de Janeiro State University

    collaborator OTHER

  • Polisa - Biopolímeros para Saúde

    lead INDUSTRY

Principal Investigators

  • Salvador VC Lima, Dr · Universidade Federal de Pernambuco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02531828 on ClinicalTrials.gov