Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border

Smith & Nephew

Status: Completed

Conditions: Wound

Treatments: Device: ALLEVYN Gentle border

Study type: Observational

Funder types: Industry

Identifiers

NCT03877484

ALLEV.PMCF.2017.13

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design