Managing Wounds With Allevyn Life in a Home Health Care Environment
| Status: | Withdrawn |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 2/10/2017 |
| Start Date: | August 2016 |
| End Date: | October 2017 |
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.
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.
INCLUSION CRITERIA
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.
EXCLUSION CRITERIA
1. Contraindications or hypersensitivity to the use of the study dressings or their
components (e.g., adhesive)
2. 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.
3. Target wound that requires daily dressing changes due to topical wound treatment
(e.g., daily applications of ointments, creams, etc.)
4. Target wound and dressing that cannot be visualized by the subject or subject's
caregiver.
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