Clinical trial NCT02053337: A RCT to Compare Performance of Two Foam Dressings on Patient Well-being Related Endpoints.
Official title: A Randomised Cross-over Clinical Evaluation to Compare Performance of ALLEVYN◊ Life and Mepilex™ Border Dressings on Patient Well-being Related Endpoints.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Wounds
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Subjective rating of the impact of the dressing performance and characteristics on patient wellbeing (referred to as patient wellbeing score)
timeFrame: After (up to) 10 days of dressing wear
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle
country: United Kingdom
facility: Northumbria NHS
Study officials:
affiliation: University of Huddersfield
name: Karen Ousey
role: PRINCIPAL_INVESTIGATOR
References: