A RCT to Compare Performance of Two Foam Dressings on Patient Well-being Related Endpoints.
NCT ID: NCT02053337
Last Updated: 2018-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2014-05-31
2015-07-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Self adhesive foam dressing
Sponsor manufactured self adhesive foam dressing. Use of CE marked dressing according to instructions for use and study protocol.
Self adhesive foam dressing
Self adhesive foam dressing
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.
Self adhesive foam dressing
Self adhesive foam dressing
Interventions
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Self adhesive foam dressing
Self adhesive foam dressing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 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.
18 Years
ALL
No
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Karen Ousey
Role: PRINCIPAL_INVESTIGATOR
University of Huddersfield
Locations
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Northumbria NHS
Newcastle, , United Kingdom
Countries
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Other Identifiers
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CE047ALF
Identifier Type: -
Identifier Source: org_study_id
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