Chronic Wounds
Conditions
Brief summary
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
Interventions
DEVICESelf adhesive foam dressing
Self adhesive foam dressing
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 Patients who have participated in this evaluation previously and have been withdrawn from the study.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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective rating of the impact of the dressing performance and characteristics on patient wellbeing (referred to as patient wellbeing score) | After (up to) 10 days of dressing wear | 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). |
Countries
United Kingdom
Outcome results
None listed