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Study Comparing the Polyurethane Films and Sugarcane Biopolymer Used as Dressings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02531828
Recruitment Status : Completed
First Posted : August 25, 2015
Last Update Posted : August 25, 2015
Universidade Federal de Pernambuco
Rio de Janeiro State University
Information provided by (Responsible Party):
Salvador Vilar Correia Lima, Universidade Federal de Pernambuco

Tracking Information
First Submitted Date  ICMJE June 12, 2014
First Posted Date  ICMJE August 25, 2015
Last Update Posted Date August 25, 2015
Study Start Date  ICMJE August 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2015)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study Comparing the Polyurethane Films and Sugarcane Biopolymer Used as Dressings
Official Title  ICMJE Expansion of Prospective Randomized Study Comparing the Polyurethane Films and Sugarcane Biopolymer Used as Dressings
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.
Detailed Description

Randomized controlled clinical trial. The target study population will comprise of the patients Unified Health System (SUS), the Outpatient Surgery and Pediatric Urology, Clinical Hospital of the Federal University of Pernambuco (UFPE), including children (from 01 years), adolescents and adults regardless of age, with lesions arising from the treatment of hypospadias, as well as other surgical injuries, according to the ethical principles outlined in Resolution 466 of the 2012 National Health Council.

Polyurethane films - Tegaderm ®

-The polyurethane films of sizes, 4.4 and 6.0 X 4.4 X 7.0 log National Agency of Sanitary Surveillance (ANVISA) / Health Ministry (MS) 10,002,070,019 manufactured by Minnesota Mining and Manufacturing Company (3M), with the following features: versatile and waterproof barrier against external contaminants, wraps to body contours promoting patient comfort.

Biopolymer film of sugarcane (POLYSHAFT ®)

-The biopolymer films of sugarcane will be provided by the research group biopolymer Sugarcane and the Experimental Station research laboratories (UFRPE). The biopolymer films have similar dimensions to the polyurethane film, which can be cut and adapted to the dimensions of the body of the patient.

All patients will be subjected to an interview being asked about previous surgery. The researcher will conduct physical and urological examination in determining the degree of hypospadias and / or other assessment procedure necessary for observation of the need (and display) the dressing with polyurethane film or biopolymer from sugar cane (POLYSHAFT®).

Patients will be randomly allocated to the groups: Biopolymer films with molasses sugar and polyurethane, using sealed, opaque, numbered envelopes containing computer-generated random distributions in 1:1 ratio in blocks of 10's envelopes will be opened in the operating room by a nurse while before starting the procedure.

All volunteers will be patients admitted to the pediatric surgery ward of the Clinical Hospital/UFPE and surgical procedures are carried out by the researchers. All patients will receive intravenous antibiotic prophylaxis at the beginning of the surgery as routine hospital clinics.

Patient recruitment and data analysis arising from the research will take place between August 2014 and August 2015, with the publication of the results expected in October 2015.

The follow-up evaluations of patients will be performed daily until removal of the bandage on the eighth postoperative day.

Variables together:

  • Rate Biocompatibility: Assessment of adverse reactions such as irritation of the skin. The researcher through observation will issue a concept: how: No skin irritability, limited to the foreskin irritability and extended to other areas irritability.
  • Degree of adherence: Assessed by the researcher through observation that deliver a concept as grip areas with detachment, grip without detachment or adhesion.
  • Degree of annoyance: Patients or their caregivers respond to the questionnaire with the concept of "very upset," "little disturbed" or "not bothered" with the dressing.
  • Grade adhesion and permanence "in situ" after being subjected to the action of water for cleaning three times a day. All observations from patient or their guardian who must be communicated to the researcher.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Wound
  • Rupture
  • Surgery
  • Cesarean Section
Intervention  ICMJE
  • Device: Application of dressings for surgical correction.
    Dressing for surgical correction
    Other Name: Polyurethane Film, or the like
  • Device: POLYSHAFT®
    Other Name: Biopolymer Film
Study Arms  ICMJE
  • Experimental: Biopolymer Film
    Application of dressings for surgical correction.
    Intervention: Device: POLYSHAFT®
  • Active Comparator: Polyurethane Film, or the like
    Application of dressings for surgical correction
    Intervention: Device: Application of dressings for surgical correction.
Publications * Martins AG, Lima SV, Araújo 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2015)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02531828
Other Study ID Numbers  ICMJE CAAE: 23402513.9.0000.5208
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Salvador Vilar Correia Lima, Universidade Federal de Pernambuco
Study Sponsor  ICMJE Polisa - Biopolímeros para Saúde
Collaborators  ICMJE
  • Universidade Federal de Pernambuco
  • Rio de Janeiro State University
Investigators  ICMJE
Principal Investigator: Salvador VC Lima, Dr Universidade Federal de Pernambuco
PRS Account Polisa - Biopolímeros para Saúde
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP