Trials / Completed
CompletedNCT03877484
Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border
A Prospective, Multi-center, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of ALLEVYN Gentle Border
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 43 (actual)
- Sponsor
- Smith & Nephew Orthopaedics AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact layer to support performance claims.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ALLEVYN Gentle border | ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film. |
Timeline
- Start date
- 2019-03-06
- Primary completion
- 2021-11-19
- Completion
- 2021-11-19
- First posted
- 2019-03-15
- Last updated
- 2024-12-09
- Results posted
- 2024-12-09
Locations
6 sites across 3 countries: France, Germany, United Kingdom
Source: ClinicalTrials.gov record NCT03877484. Inclusion in this directory is not an endorsement.