Study Comparing the Polyurethane Films and Sugarcane Biopolymer Used as Dressings
Expansion of Prospective Randomized Study Comparing the Polyurethane Films and Sugarcane Biopolymer Used as Dressings
1 other identifier
interventional
141
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2014
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedFirst Posted
Study publicly available on registry
August 25, 2015
CompletedAugust 25, 2015
August 1, 2015
11 months
June 12, 2014
August 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
The safety was assessed by adverse event reports, such as skin irritability next to the dressing area, categorized by feeling of warmth, itching, swelling, pain, and hyperemia.
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
Secondary Outcomes (1)
Efficacy of the Film of the Sugarcane Biopolymer
For time-to-event outcome measures, the time frame estimated was the 24 months.
Study Arms (2)
Biopolymer Film
EXPERIMENTALApplication of dressings for surgical correction.
Polyurethane Film, or the like
ACTIVE COMPARATORApplication of dressings for surgical correction
Interventions
Dressing for surgical correction
Eligibility Criteria
You may qualify if:
- Patients with Age between 01 and 18 years and adults, regardless of age.
You may not qualify if:
- Patients with clinical complications or associated diseases that contraindication of surgical wound dressing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Polisa - Biopolímeros para Saúdelead
- Universidade Federal de Pernambucocollaborator
- Rio de Janeiro State Universitycollaborator
Study Sites (1)
Federal University of Pernambuco
Recife, Pernambuco, 50670-90150670-901, Brazil
Related Publications (1)
Martins AG, Lima SV, Araujo LA, Vilar Fde O, Cavalcante NT. A wet dressing for hypospadias surgery. Int Braz J Urol. 2013 May-Jun;39(3):408-13. doi: 10.1590/S1677-5538.IBJU.2013.03.15.
PMID: 23849573RESULT
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Salvador VC Lima, Dr
Universidade Federal de Pernambuco
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor IV
Study Record Dates
First Submitted
June 12, 2014
First Posted
August 25, 2015
Study Start
August 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
August 25, 2015
Record last verified: 2015-08