Chronic WoundsNCT02053337
A RCT to Compare Performance of Two Foam Dressings on Patient Well-being Related Endpoints.
A study testing Self adhesive foam dressing in people with Chronic Wounds, run by Smith & Nephew, Inc. at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Wounds
- What is being tested?
- Self adhesive foam dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Chronic Wounds
- Being tested
- Self adhesive foam dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self adhesive foam dressingDevice
Also called ALLEVYN◊ Life
Self adhesive foam dressing
| Study group | Role | What they receive |
|---|---|---|
| Self adhesive foam dressing | Experimental | Sponsor manufactured self adhesive foam dressing. Use of CE marked dressing according to instructions for use and study protocol. Receives: Device: Self adhesive foam dressing |
| Comparator self adhesive foam dressing | Active comparator | Non Sponsor manufactured self adhesive foam dressing. Use of CE marked dressing according to instructions for use and study protocol. Receives: Device: Self adhesive foam dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: After (up to) 10 days of dressing wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic WoundsStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Ousey, Principal investigator, University of Huddersfield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053337
- Sponsor's protocol ID
- CE047ALF
- Status last verified
- Feb 2018
- First submitted
- 20 Jan 2014
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Cross-over Clinical Evaluation to Compare Performance of ALLEVYN◊ Life and Mepilex™ Border Dressings on Patient Well-being Related Endpoints.
- ClinicalTrials.gov ID
- NCT02053337
- Acronym / sponsor ID
- CE047ALF
- Conditions
- Chronic Wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self adhesive foam dressing | Experimental | Device: Self adhesive foam dressingSponsor manufactured self adhesive foam dressing. Use of CE marked dressing according to instructions for use and study protocol. |
| Comparator self adhesive foam dressing | Active comparator | Device: Self adhesive foam dressingNon Sponsor manufactured self adhesive foam dressing. Use of CE marked dressing according to instructions for use and study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self adhesive foam dressingAlso: ALLEVYN◊ LifeSelf adhesive foam dressing | Device | Comparator self adhesive foam dressing, Self adhesive foam dressing |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Ousey principal investigator
University of Huddersfield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self adhesive foam dressing in people with Chronic Wounds, run by Smith & Nephew, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.