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
|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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||141 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Biopolymer Film
Application of dressings for surgical correction.
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
- 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.
- 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).
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
|Federal University of Pernambuco|
|Recife, Pernambuco, Brazil, 50670-90150670-901|
|Principal Investigator:||Salvador VC Lima, Dr||Universidade Federal de Pernambuco|