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Study Comparing the Polyurethane Films and Sugarcane Biopolymer Used as Dressings

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ClinicalTrials.gov Identifier: NCT02531828
Recruitment Status : Completed
First Posted : August 25, 2015
Last Update Posted : August 25, 2015
Sponsor:
Collaborators:
Universidade Federal de Pernambuco
Rio de Janeiro State University
Information provided by (Responsible Party):
Salvador Vilar Correia Lima, Universidade Federal de Pernambuco

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.

Condition or disease Intervention/treatment Phase
Wound Rupture Surgery Cesarean Section Device: Application of dressings for surgical correction. Device: POLYSHAFT® Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Expansion of Prospective Randomized Study Comparing the Polyurethane Films and Sugarcane Biopolymer Used as Dressings
Study Start Date : August 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Arm Intervention/treatment
Experimental: Biopolymer Film
Application of dressings for surgical correction.
Device: POLYSHAFT®
Other Name: Biopolymer Film

Active Comparator: Polyurethane Film, or the like
Application of dressings for surgical correction
Device: Application of dressings for surgical correction.
Dressing for surgical correction
Other Name: Polyurethane Film, or the like




Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 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 ]
    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.


Secondary Outcome Measures :
  1. Efficacy of the Film of the Sugarcane Biopolymer [ Time Frame: For time-to-event outcome measures, the time frame estimated was the 24 months. ]
    The efficacy was classified according to the grade of adhesiveness in the wound area (fully adhered, partially detached or without adhesiveness); the discomfort (described during the questionnaire as "very troubled", "troubled" or "not troubled" with the use of the dressing); and the transudation (this aspect was evaluated by the exudates drainage and its ability to retain wet).



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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Age between 01 and 18 years and adults, regardless of age.

Exclusion Criteria:

  • Patients with clinical complications or associated diseases that contraindication of surgical wound dressing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531828


Locations
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Brazil
Federal University of Pernambuco
Recife, Pernambuco, Brazil, 50670-90150670-901
Sponsors and Collaborators
Polisa - Biopolímeros para Saúde
Universidade Federal de Pernambuco
Rio de Janeiro State University
Investigators
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Principal Investigator: Salvador VC Lima, Dr Universidade Federal de Pernambuco

Publications of Results:
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Responsible Party: Salvador Vilar Correia Lima, Associate Professor IV, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02531828     History of Changes
Other Study ID Numbers: CAAE: 23402513.9.0000.5208
First Posted: August 25, 2015    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries