Completed

NCT Number: NCT02053337

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

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

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Key information

Conditions

Chronic Wounds

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northumbria NHS

Newcastle, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Self adhesive foam dressing

Device

Self adhesive foam dressing

Other names: ALLEVYN◊ Life

Primary outcomes

Subjective rating of the impact of the dressing performance and characteristics on patient wellbeing (referred to as patient wellbeing score)

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Feb 3, 2014
Registry last updated: Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed