Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border

Study Overview
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Brief Summary
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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.

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

Conditions
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Wound

Intervention / Treatment
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* Device: ALLEVYN Gentle border


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent. 18 years of age or older. Willing and able to make all required study visits. Able to follow instructions and deemed capable of completing the CWIS questionnaire, Patient Assessment Scale and Pain Scale. Presence of a moderately to highly exuding wound of at least 3cm2 in size. 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 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: Subjects with confirmed or suspected clinically infected reference wound. Reference wound undergoing treatment with compression therapy. Contraindications or hypersensitivity to the use of the ALLEVYN Gentle Border. Participation in the treatment period of another clinical trial within 30 days of Visit 1 or planned participation overlapping with this study. 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. Subjects who have participated previously in this clinical trial. Subjects with a history of poor compliance with medical treatment. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance as measured by change in size of the wound area (cm2) over 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 |  | up to 21 days | 
| Absolute change in wound depth (mm) from baseline to days 7, 14, 21 and 28 |  | up to 28 days | 
| Percentage change in wound area from baseline to days 7, 14, 21 and 28 |  | up to 28 days | 
| Frequency of wound dressing performance measures at days 7, 14, 21 and 28 | 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 |  | 28 days | 
| Number of patients with Adverse Events and Device Deficiencies |  | 28 days | 
| Absolute change in wound volume (cm3) from baseline to days 7, 14, 21 and 28 |  | up to 28 days | 
| Percentage change in wound depth from baseline to days 7, 14, 21 and 28 |  | up to 28 days | 
| Percentage change in wound volume from baseline to days 7, 14, 21 and 28 |  | up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic foot ulcers, full-thickness, chronic and acute wounds, partial thickness, shadow granulating, exuding wounds, including pressure ulcers, leg ulcers, dehisced surgical wounds