Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border

NCT ID: NCT03877484

Last Updated: 2024-12-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-06
• Study Completion Date: 2021-11-19

Brief 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

Keywords

chronic and acute wounds; full-thickness; partial thickness; shadow granulating; exuding wounds; including pressure ulcers; leg ulcers; diabetic foot ulcers; dehisced surgical wounds

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew Orthopaedics AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uwe Reinhold, MD

Role: PRINCIPAL_INVESTIGATOR

VZ Dermatologisches Zentrum Bonn

Cornelia Erfurt-Berge, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Erlangen, Department of Dermatology

Ulrike Raap, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Oldenburg, Universitätsklinik für Dermatologie und Allergologie

Locations

Centre Hospitalier William Morey

Chalon-sur-Saône, , France

MVZ Dermatologisches Zentrum Bonn GmbH

Bonn, , Germany

University Hospital Erlangen, Department of Dermatology

Erlangen, , Germany

Niels-Stensen-Kliniken Christliches Klinikum Melle GmbH

Melle, , Germany

Klinikum Oldenburg, University Clinic for Dermatology and Allergy

Oldenburg, , Germany

Northumbria Healthcare NHS Foundation Trust

Ashington, Northumberland, United Kingdom

Countries

France; Germany; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ALLEV.PMCF.2017.13

Identifier Type: -

Identifier Source: org_study_id