Wounds and InjuriesNCT02776800
Managing Wounds With Allevyn Life in a Home Health Care Environment
A study testing Allevyn Life and Foam dressing with an integrated adhesive border in people with Wounds and Injuries, run by Smith & Nephew, Inc. at 3 sites in United States.
Trial summary
When elderly patients need help caring for wounds, physicians may refer patients to home health care providers. The home health provider sees the patient in the patient's home and assists the patient with wound care. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Allevyn Life and Foam dressing with an integrated adhesive border
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2016to Oct 2017
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 1. The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. 2. Subjects sixty-five (65) years of age or older. Subjects may be of either sex and of any race.
- 3. Willing and able to allow home health clinician to conduct all required study visits.
- 4. The subject (or caregiver) must be able to follow instructions, including the ability to have regular contact with the home health clinician between study visits.
- 5. Are covered by traditional Medicare. 6. Have a wound that is suitable for treatment with a foam dressing and can be appropriately covered by a single piece of ALLEVYN Life or the comparator dressing.
- 7. At Screening, wound exudate must be moderate to heavy, as determined by the home health clinician.
- 8. Target wound may be a trauma wound, chronic wound, or post-surgical wound. 9. Wound care is the primary reason for the home health clinician visits and determines the frequency of home health visits. Subjects may have other comorbidities, but these cannot be the determining factor in scheduling the frequency of the home health visits.
Who cannot join
- Contraindications or hypersensitivity to the use of the study dressings or their components (e.g., adhesive)
- Any wound that requires an additional covering (e.g., compression dressing, cast, etc.) over the study dressing that prevents daily visualization of the dressing under study.
- Target wound that requires daily dressing changes due to topical wound treatment (e.g., daily applications of ointments, creams, etc.)
- Target wound and dressing that cannot be visualized by the subject or subject's caregiver.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
McAllen, Texas, 78501
Study site
Tustin, California, 92780
Study site
Wichita, Kansas, 67203
About this study
Official title: A Randomized, Controlled Study of Allevyn Life in the Management of Wounds in Home Health Care
When elderly patients need help caring for wounds, physicians may refer patients to home health care providers. The home health provider sees the patient in the patient's home and assists the patient with wound care. Working with the patient's physician, the home health provider will use the appropriate wound covering ("dressing" or "bandage") to cover the wound. The goal of the home health provider is to ensure that the wound stays clean and progresses toward closure. The home health provider will conduct in-home patient visits at appropriate intervals to assess the status of the wound.
Extensive resources are required to see patients in their own homes. If a dressing could effectively manage wounds and allow longer time between in-home visits (without affecting patient safety or progress of the wound toward closure), then resources could be saved. Thus, newer dressings are designed for longer wear times, using advanced foam pads and adhesives that help keep the dressing in place. The hypothesis of this study is that the use of Allevyn Life will decrease the number of in-home visits by home health providers without sacrificing patient safety.
- Conditions
- Wounds and Injuries
- Being tested
- Allevyn Life, Foam dressing with an integrated adhesive border
- Keywords
- Wound, Surgical Wound, Trauma Wound, Home Health Care, Home Health Nurse, Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer, Arterial Ulcer, Wound Dehiscence, Open Wound
- Medical subject headings
- Wounds and Injuries, Surgical Wound, Pressure Ulcer, Diabetic Foot, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allevyn LifeDevice
Foam dressing with an integrated adhesive borderDevice
Foam dressing normally used by the home health agency
| Study group | Role | What they receive |
|---|---|---|
| Allevyn Life | Experimental | Foam Dressing Receives: Device: Allevyn Life |
| Foam Dressing | Other | Standard Care - Foam Dressing Receives: Device: Foam dressing with an integrated adhesive border |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of home health clinician visits in each group
Measured: 60 days
Secondary outcomes (5)
Home health provider time on-site
Measured: 60 days
Total cost of each treatment group
Measured: 60 days
Number of visits required compared to number initially anticipated
Measured: 60 days
Assess the Cardiff Wound Impact Schedule
Measured: 60 days
Average dressing wear time
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startAug 2016 (estimated)
- Primary completionJul 2017 (estimated)
- Study completionOct 2017 (estimated)
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert B Slade, MD, Study chair, Smith & Nephew, Inc.Jaime E Dickerson, PhD, Study director, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776800
- Sponsor's protocol ID
- CE054ALF
- Status last verified
- Feb 2017
- First submitted
- 16 May 2016
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study of Allevyn Life in the Management of Wounds in Home Health Care
- ClinicalTrials.gov ID
- NCT02776800
- Acronym / sponsor ID
- CE054ALF
- Conditions
- Wounds and Injuries
- Keywords
- Wound, Surgical Wound, Trauma Wound, Home Health Care, Home Health Nurse, Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2016 (estimated)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 18 May 2016 (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.
When elderly patients need help caring for wounds, physicians may refer patients to home health care providers. The home health provider sees the patient in the patient's home and assists the patient with wound care. Working with the patient's physician, the home health provider will use the appropriate wound covering ("dressing" or "bandage") to cover the wound. The goal of the home health provider is to ensure that the wound stays clean and progresses toward closure. The home health provider will conduct in-home patient visits at appropriate intervals to assess the status of the wound.
Extensive resources are required to see patients in their own homes. If a dressing could effectively manage wounds and allow longer time between in-home visits (without affecting patient safety or progress of the wound toward closure), then resources could be saved. Thus, newer dressings are designed for longer wear times, using advanced foam pads and adhesives that help keep the dressing in place. The hypothesis of this study is that the use of Allevyn Life will decrease the number of in-home visits by home health providers without sacrificing patient safety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allevyn Life | Experimental | Device: Allevyn LifeFoam Dressing |
| Foam Dressing | Other | Device: Foam dressing with an integrated adhesive borderStandard Care - Foam Dressing |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 1. The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. 2. Subjects sixty-five (65) years of age or older. Subjects may be of either sex and of any race.
- 3. Willing and able to allow home health clinician to conduct all required study visits.
- 4. The subject (or caregiver) must be able to follow instructions, including the ability to have regular contact with the home health clinician between study visits.
- 5. Are covered by traditional Medicare. 6. Have a wound that is suitable for treatment with a foam dressing and can be appropriately covered by a single piece of ALLEVYN Life or the comparator dressing.
- 7. At Screening, wound exudate must be moderate to heavy, as determined by the home health clinician.
Key exclusion criteria (4 listed)
- Contraindications or hypersensitivity to the use of the study dressings or their components (e.g., adhesive)
- Any wound that requires an additional covering (e.g., compression dressing, cast, etc.) over the study dressing that prevents daily visualization of the dressing under study.
- Target wound that requires daily dressing changes due to topical wound treatment (e.g., daily applications of ointments, creams, etc.)
- Target wound and dressing that cannot be visualized by the subject or subject's caregiver.
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 |
|---|---|---|
| Allevyn Life | Device | Allevyn Life |
| Foam dressing with an integrated adhesive borderFoam dressing normally used by the home health agency | Device | Foam Dressing |
Primary outcome
Number of home health clinician visits in each group
Time frame: 60 days
5 secondary outcomes
Home health provider time on-site
Time frame: 60 days
Total cost of each treatment group
Time frame: 60 days
Number of visits required compared to number initially anticipated
Time frame: 60 days
Assess the Cardiff Wound Impact Schedule
Time frame: 60 days
Average dressing wear time
Time frame: 60 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Herbert B Slade, MD study chair
Smith & Nephew, Inc.
Jaime E Dickerson, PhD study director
Smith & Nephew, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allevyn Life and Foam dressing with an integrated adhesive border in people with Wounds and Injuries, run by Smith & Nephew, Inc. at 3 sites in United States.
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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of home health clinician visits in each group (time frame: 60 days). 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 9 Feb 2017.