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Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border

NCT03877484 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2024-12-09

Study results available
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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

  • Wound

Interventions

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.

Sponsors & Collaborators

  • Smith & Nephew Orthopaedics AG

    lead INDUSTRY

Principal Investigators

  • Uwe Reinhold, MD · VZ Dermatologisches Zentrum Bonn

  • Cornelia Erfurt-Berge, MD · University Hospital Erlangen, Department of Dermatology

  • Ulrike Raap, MD · Klinikum Oldenburg, Universitätsklinik für Dermatologie und Allergologie

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-06
Primary Completion
2021-11-19
Completion
2021-11-19

Countries

  • France
  • Germany
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03877484 on ClinicalTrials.gov