A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Performance and Safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive Dressings in the Management of Surgical and Traumatic Wounds
NCT ID: NCT05632276
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2023-06-08
2024-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ConvaFoam dressings
Participants wounds will be assessed and will be allocated ConvaFoam Border, Silicone or Non-Adhesive dressing based upon the investigator's clinical judgment. participants will receive a dressing as part of a protocol of care for up to a period of 4 weeks
ConvaFoam
ConvaFoam™ Border, ConvaFoam™ Non-Adhesive, and ConvaFoam™ Silicone dressings are designed to provide a moist wound healing environment. All participants will be assigned a dressing based upon clinical judgement for a maximum of 4 weeks with weekly assessments and dressing changes
Interventions
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ConvaFoam
ConvaFoam™ Border, ConvaFoam™ Non-Adhesive, and ConvaFoam™ Silicone dressings are designed to provide a moist wound healing environment. All participants will be assigned a dressing based upon clinical judgement for a maximum of 4 weeks with weekly assessments and dressing changes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients able and willing to provide informed consent
* Patients with Surgical wounds including incisional wounds including laparoscopic
* wounds and surgical wounds healing by secondary intention.
* Patients with Traumatic wounds
* Patients must be willing to attend visits as per schedule in protocol
Exclusion Criteria
* Patients who require any oxidising agents such as hydrogen peroxide or hypochlorite solutions.
* Patients, who in the opinion of the investigator, is considered unsuitable for any other reason
* Patients with wounds showing signs of infection on presentation or not resolving with the use of antibiotics
18 Years
ALL
No
Sponsors
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ConvaTec Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kerem Ozer, MD
Role: STUDY_CHAIR
Medical Director
Locations
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Boston Medical Center
Boston, Massachusetts, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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WC-22-440
Identifier Type: -
Identifier Source: org_study_id
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