Study Comparing the Polyurethane Films and Sugarcane Biopolymer Used as Dressings

August 24, 2015 updated by: Salvador Vilar Correia Lima, Polisa - Biopolímeros para Saúde

Expansion of Prospective Randomized Study Comparing the Polyurethane Films and Sugarcane Biopolymer Used as Dressings

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

141

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50670-90150670-901
        • Federal University of Pernambuco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biopolymer Film
Application of dressings for surgical correction.
Device: POLYSHAFT®
Other Names:
  • 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 Names:
  • Polyurethane Film, or the like

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
For time-to-event outcome measures, the time frame estimated was the 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Polisa - Biopolímeros para Saúde

Collaborators

Rio de Janeiro State University
Universidade Federal de Pernambuco

Investigators

  • Principal Investigator: Salvador VC Lima, Dr, Universidade Federal de Pernambuco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

June 12, 2014

First Submitted That Met QC Criteria

August 24, 2015

First Posted (Estimate)

August 25, 2015

Study Record Updates

Last Update Posted (Estimate)

August 25, 2015

Last Update Submitted That Met QC Criteria

August 24, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE: 23402513.9.0000.5208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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