Managing Wounds With Allevyn Life in a Home Health Care Environment

NCT ID: NCT02776800

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-10-31

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.

Conditions

Wounds and Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Allevyn Life

Foam Dressing

Group Type: EXPERIMENTAL

Allevyn Life

Intervention Type: DEVICE

Foam Dressing

Standard Care - Foam Dressing

Group Type: OTHER

Foam dressing with an integrated adhesive border

Intervention Type: DEVICE

Foam dressing normally used by the home health agency

Interventions

Allevyn Life

Intervention Type: DEVICE

Foam dressing with an integrated adhesive border

Foam dressing normally used by the home health agency

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herbert B Slade, MD

Role: STUDY_CHAIR

Smith & Nephew, Inc.

Jaime E Dickerson, PhD

Role: STUDY_DIRECTOR

Smith & Nephew, Inc.

Locations

Tustin, California, United States

Wichita, Kansas, United States

McAllen, Texas, United States

Countries

United States

Other Identifiers

CE054ALF

Identifier Type: -

Identifier Source: org_study_id