A RCT to Compare Performance of Two Foam Dressings on Patient Well-being Related Endpoints.

Study Overview
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Brief Summary
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ALLEVYN◊ Life and Mepilex™ Border are both layered foam dressings with a silicone adhesive wound contact layer. Both are indicated for the same uses; however ALLEVYN◊ Life has a number of attributes designed to meet a range of characteristics associated with principles of wellbeing. The aim for this evaluation is to assess, in a clinical setting and against a number of identified criteria, the performance of the ALLEVYN◊ Life dressing compared to Mepilex™ Border in terms of characteristics of the attributes of wellbeing. ◊ Trademark of Smith & Nephew ™ All trademarks acknowledged

Official Title
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A Randomised Cross-over Clinical Evaluation to Compare Performance of ALLEVYN◊ Life and Mepilex™ Border Dressings on Patient Well-being Related Endpoints.

Conditions
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Chronic Wounds

Intervention / Treatment
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* Device: Self adhesive foam dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 years old Males and females (females must not be pregnant and must use contraception if of child bearing potential.) Presence of a single suitable wound which can be the reference wound without treatment impacting on any other wound(s) on the patient. Presence of a suitable wound which can be treated with the available sizes and shapes of ALLEVYN◊ Life (10.3cm X 10.3cm, 12.9cm X 12.9cm, 15.4cm X 15.4cm, 21cm X 21cm) and Mepilex™ Border (7cm X 7.5cm, 10cm X 12.5cm, 15cm X 17.5, 17cm X 20cm) Presence of an exuding wound of at least 6 weeks duration at the point of enrolment, healing by secondary intention The patient is able to understand the evaluation and is willing to consent to the evaluation. The patient is available to participate for the anticipated duration of the evaluation. Exclusion Criteria: Patients with confirmed or suspected clinically infected reference wounds. Patients with wounds that, in the opinion of the clinician, is likely to heal within a time period of 4 weeks from point of enrolment. Patients with a reference wound undergoing treatment with compression therapy. Patients where a reference wound cannot be treated in isolation from other wounds. Patients with deep reference wounds that, in the opinion of the clinician, necessitate filler material. Patients with a known sensitivity to any of the constituents of the evaluation products. Patients with a known history of poor compliance with medical treatment. Patients who have participated in this evaluation previously and have been withdrawn from the study. Patients unable to understand or speak the English language. Patients without the capacity to understand and answer wellbeing related questions Females who are pregnant or breast feeding.

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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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self adhesive foam dressing<br>Sponsor manufactured self adhesive foam dressing. Use of CE marked dressing according to instructions for use and study protocol. | Device: Self adhesive foam dressing<br>* Self adhesive foam dressing<br>* Other names: ALLEVYN◊ Life;|
| Active Comparator: Comparator self adhesive foam dressing<br>Non Sponsor manufactured self adhesive foam dressing. Use of CE marked dressing according to instructions for use and study protocol. | Device: Self adhesive foam dressing<br>* Self adhesive foam dressing<br>* Other names: ALLEVYN◊ Life;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective rating of the impact of the dressing performance and characteristics on patient wellbeing (referred to as patient wellbeing score) | The primary outcome, a subjective patient wellbeing/preference score, is calculated using a combination of responses from 8 individual questions on a patient questionnaire and 2 further dressing retention related measures at the end of treatment with each dressing (up to maximum of 10 days). Individual patient questions relate to the effect of specific dressing performance /characteristics on patient wellbeing (each on a 0-10 scale: 0 = most negative response, 10 = most positive response). | After (up to) 10 days of dressing wear |