WoundPhase 3NCT02531828
Study Comparing the Polyurethane Films and Sugarcane Biopolymer Used as Dressings
A Phase 3 study testing Application of dressings for surgical correction. and POLYSHAFT® in people with Wound and Rupture, run by Polisa - Biopolímeros para Saúde at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- What is being tested?
- Application of dressings for surgical correction. and POLYSHAFT®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2014to Jul 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with Age between 01 and 18 years and adults, regardless of age.
Who cannot join
- Patients with clinical complications or associated diseases that contraindication of surgical wound dressing.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Pernambuco
Recife, Pernambuco, 50670-90150670-901
About this study
Official title: 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.
Read the 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.
- Conditions
- Wound, Rupture, Surgery, Cesarean Section
- Being tested
- Application of dressings for surgical correction., POLYSHAFT®
- Medical subject headings
- Wounds and Injuries, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of dressings for surgical correction.Device
Also called Polyurethane Film, or the like
Dressing for surgical correction
POLYSHAFT®Device
Also called Biopolymer Film
| Study group | Role | What they receive |
|---|---|---|
| Biopolymer Film | Experimental | Application of dressings for surgical correction. Receives: Device: POLYSHAFT® |
| Polyurethane Film, or the like | Active comparator | Application of dressings for surgical correction Receives: Device: Application of dressings for surgical correction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: For time-to-event outcome measures, the time frame estimated was the 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startAug 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polisa - Biopolímeros para Saúde
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidade Federal de Pernambuco, Rio de Janeiro State University
- Responsible party
- Principal investigator, Salvador Vilar Correia Lima, Universidade Federal de Pernambuco
- Investigators
- Salvador VC Lima, Dr, Principal investigator, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531828
- Sponsor's protocol ID
- CAAE: 23402513.9.0000.5208
- Status last verified
- Aug 2015
- First submitted
- 12 Jun 2014
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23849573
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expansion of Prospective Randomized Study Comparing the Polyurethane Films and Sugarcane Biopolymer Used as Dressings
- ClinicalTrials.gov ID
- NCT02531828
- Acronym / sponsor ID
- CAAE: 23402513.9.0000.5208
- Conditions
- Wound, Rupture, Surgery, Cesarean Section
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Polisa - Biopolímeros para SaúdeIndustry (pharma, biotech, devices)
- Collaborators
- Universidade Federal de Pernambuco, Rio de Janeiro State University
- Study start
- Aug 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biopolymer Film | Experimental | Device: POLYSHAFT®Application of dressings for surgical correction. |
| Polyurethane Film, or the like | Active comparator | Device: Application of dressings for surgical correction.Application of dressings for surgical correction |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Age between 01 and 18 years and adults, regardless of age.
Key exclusion criteria (1 listed)
- Patients with clinical complications or associated diseases that contraindication of surgical wound dressing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of dressings for surgical correction.Also: Polyurethane Film, or the likeDressing for surgical correction | Device | Polyurethane Film, or the like |
| POLYSHAFT®Also: Biopolymer Film | Device | Biopolymer Film |
Primary outcome
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.
1 secondary outcome
Efficacy of the Film of the Sugarcane Biopolymer
Time frame: For time-to-event outcome measures, the time frame estimated was the 24 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
- Results publication: PubMed 23849573Martins 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvador VC Lima, Dr principal investigator
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Application of dressings for surgical correction. and POLYSHAFT® in people with Wound and Rupture, run by Polisa - Biopolímeros para Saúde at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02531828, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2015.