At a glance
ClinicalIndex Comparison RecordN/ACompleted· 43 enrolled
Drug / intervention
ALLEVYN Gentle borderdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multi-center, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of ALLEVYN Gentle Border
In Brief
An observational study evaluating ALLEVYN Gentle border for Wound. Completed, enrolled 43 participants across 6 sites in 3 countries.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsWound
CountriesFrance, Germany, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
20192020202120222023202420252026
Enrollment StartMar 2019
First PostedMar 2019
Primary CompletionNov 2021
TodayJul 2026
First PostedMar 15, 2019
Enrollment StartMar 6, 2019
Primary CompletionNov 19, 2021
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.3 years ago
Interventions
ALLEVYN Gentle borderdevice
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.