Trials / Completed
CompletedNCT05632276
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- ConvaTec Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Detailed description
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 for up to 4 weeks
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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 |
Timeline
- Start date
- 2023-06-08
- Primary completion
- 2024-03-13
- Completion
- 2024-03-13
- First posted
- 2022-11-30
- Last updated
- 2024-04-30
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05632276. Inclusion in this directory is not an endorsement.