Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border

December 13, 2021 updated by: Smith & Nephew Orthopaedics AG

A Prospective, Multi-center, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of ALLEVYN Gentle Border

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Chalon-sur-Saône, France, 71321
        • Centre Hospitalier William Morey
      • Bonn, Germany, 53111
        • MVZ Dermatologisches Zentrum Bonn GmbH
      • Erlangen, Germany, 91054
        • University Hospital Erlangen, Department of Dermatology
      • Melle, Germany, 49324
        • Niels-Stensen-Kliniken Christliches Klinikum Melle GmbH
      • Oldenburg, Germany, 26133
        • Klinikum Oldenburg, University Clinic for Dermatology and Allergy
    • Northumberland
      • Ashington, Northumberland, United Kingdom, NE63 0HP
        • Northumbria Healthcare NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Forty adult subjects with moderate to highly exuding wounds that require a dressing will be recruited. Only subjects with acute wounds or chronic wounds which are present > 6 weeks will be enrolled. Chronic wounds will include pressure ulcers, leg ulcers, diabetic foot ulcers. Acute wounds will include dehisced surgical or traumatic wounds. In order to ensure a balanced distribution on chronic and acute indications, at least 10 subjects with chronic wounds and at least 10 subjects with acute wounds will be enrolled.

Description

Inclusion Criteria:

  1. Signed written informed consent.
  2. 18 years of age or older.
  3. Willing and able to make all required study visits.
  4. Able to follow instructions and deemed capable of completing the CWIS questionnaire, Patient Assessment Scale and Pain Scale.
  5. Presence of a moderately to highly exuding wound of at least 3cm2 in size.
  6. Presence of a chronic wound of at least 6 weeks duration at the point of enrollment; full-thickness, partial thickness or shallow granulating wounds.

    Chronic wounds include:

    • pressure ulcers or
    • leg ulcers or
    • diabetic foot ulcers

    or

    Presence of an acute wound at the point of enrollment; full thickness, partial thickness or shallow granulating wounds

    Acute wounds include:

    • dehisced surgical or
    • traumatic wounds
  7. The patient has a wound size which can be treated with the available sizes and shapes of ALLEVYN Gentle Border. Cutting of the dressing is allowed, if needed. ALLEVYN Gentle Border can be cut and an aseptic technique should be used with cutting the dressing. Ensure any exposed foam areas are covered with an appropriate film dressing taking care not to cover the entire dressing.

Exclusion Criteria:

  1. Subjects with confirmed or suspected clinically infected reference wound.
  2. Reference wound undergoing treatment with compression therapy.
  3. Contraindications or hypersensitivity to the use of the ALLEVYN Gentle Border.
  4. Participation in the treatment period of another clinical trial within 30 days of Visit 1 or planned participation overlapping with this study.
  5. Subjects with skin features (e.g. tattoos, skin color, pre-existing scarring) which, in the opinion of the Investigator, could interfere with the study assessments.
  6. Subjects who have participated previously in this clinical trial.
  7. Subjects with a history of poor compliance with medical treatment.
  8. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical performance as measured by change in size of the wound area (cm2) over 4 weeks
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change in wound area from baseline to days 7, 14 and 21
Time Frame: up to 21 days
up to 21 days
Absolute change in wound depth (mm) from baseline to days 7, 14, 21 and 28
Time Frame: up to 28 days
up to 28 days
Percentage change in wound area from baseline to days 7, 14, 21 and 28
Time Frame: up to 28 days
up to 28 days
Frequency of wound dressing performance measures at days 7, 14, 21 and 28
Time Frame: up to 28 days
Description: Clinical and Dressing performance endpoints include: exudate type, amount and viscosity, odour control, dressing change frequency, condition of surrounding skin, signs of clinical infection, healing of reference wound, dressing wear time, dressing retention, presence of bunching up, percentage dressing lift, comfort during wear, showerproof qualities and pain on application, during treatment and on dressing removal.
up to 28 days
Change from baseline in subject reported outcomes using the Cardiff Wound Impact Schedule
Time Frame: 28 days
28 days
Number of patients with Adverse Events and Device Deficiencies
Time Frame: 28 days
28 days
Absolute change in wound volume (cm3) from baseline to days 7, 14, 21 and 28
Time Frame: up to 28 days
up to 28 days
Percentage change in wound depth from baseline to days 7, 14, 21 and 28
Time Frame: up to 28 days
up to 28 days
Percentage change in wound volume from baseline to days 7, 14, 21 and 28
Time Frame: up to 28 days
up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Uwe Reinhold, MD, VZ Dermatologisches Zentrum Bonn
  • Principal Investigator: Cornelia Erfurt-Berge, MD, University Hospital Erlangen, Department of Dermatology
  • Principal Investigator: Ulrike Raap, MD, Klinikum Oldenburg, Universitätsklinik für Dermatologie und Allergologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 6, 2019

Primary Completion (ACTUAL)

November 19, 2021

Study Completion (ACTUAL)

November 19, 2021

Study Registration Dates

First Submitted

February 6, 2019

First Submitted That Met QC Criteria

March 13, 2019

First Posted (ACTUAL)

March 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 14, 2021

Last Update Submitted That Met QC Criteria

December 13, 2021

Last Verified

December 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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