Clinical trial NCT02776800: Managing Wounds With Allevyn Life in a Home Health Care Environment
Official title: A Randomized, Controlled Study of Allevyn Life in the Management of Wounds in Home Health Care
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Wounds and Injuries
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
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of home health clinician visits in each group
timeFrame: 60 days
Secondary outcomes:
measure: Home health provider time on-site
timeFrame: 60 days
measure: Total cost of each treatment group
timeFrame: 60 days
measure: Number of visits required compared to number initially anticipated
timeFrame: 60 days
measure: Assess the Cardiff Wound Impact Schedule
timeFrame: 60 days
measure: Average dressing wear time
timeFrame: 60 days
Other outcomes:
Locations:
city: Tustin
country: United States
state: California
city: Wichita
country: United States
state: Kansas
city: McAllen
country: United States
state: Texas
Study officials:
affiliation: Smith & Nephew, Inc.
name: Herbert B Slade, MD
role: STUDY_CHAIR
affiliation: Smith & Nephew, Inc.
name: Jaime E Dickerson, PhD
role: STUDY_DIRECTOR
References: