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

A Randomised Cross-over Clinical Evaluation to Compare Performance of ALLEVYN◊ Life and Mepilex™ Border 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

Study Overview

• Status: Completed
• Conditions: Chronic Wounds
• Intervention / Treatment: Device: Self adhesive foam dressing

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Newcastle, United Kingdom
    • Northumbria NHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Karen Ousey, University of Huddersfield

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: January 20, 2014
• First Submitted That Met QC Criteria: January 31, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 14, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CE047ALF