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

Chronic Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053337
• Other study ID #: CE047ALF
• Status: Completed
• Phase: N/A
• First received: January 20, 2014
• Last updated: February 14, 2018
• Start date: May 2014
• Est. completion date: July 2015

Study information

• Verified date: February 2018
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Wounds

Intervention

Device:
• Self adhesive foam dressing
Self adhesive foam dressing

Locations

Country	Name	City	State
United Kingdom	Northumbria NHS	Newcastle

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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