Managing Wounds With Allevyn Life in a Home Health Care Environment

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.

Study Overview

• Status: Withdrawn
• Conditions: Wounds and Injuries
• Intervention / Treatment: Device: Allevyn Life; Device: Foam dressing with an integrated adhesive border

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Tustin, California, United States, 92780
  • Kansas
    • Wichita, Kansas, United States, 67203
  • Texas
    • McAllen, Texas, United States, 78501

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Allevyn Life; Foam Dressing	Device: Allevyn Life
OTHER: Foam Dressing; Standard Care - Foam Dressing	Device: Foam dressing with an integrated adhesive border; Foam dressing normally used by the home health agency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of home health clinician visits in each group	60 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Home health provider time on-site	60 days
Total cost of each treatment group	60 days
Number of visits required compared to number initially anticipated	60 days
Assess the Cardiff Wound Impact Schedule	60 days
Average dressing wear time	60 days

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2016
• Primary Completion (ANTICIPATED): July 1, 2017
• Study Completion (ANTICIPATED): October 1, 2017

Study Registration Dates

• First Submitted: May 16, 2016
• First Submitted That Met QC Criteria: May 16, 2016
• First Posted (ESTIMATE): May 18, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 8, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Wound; Diabetic Foot Ulcer; Pressure Ulcer; Surgical Wound; Venous Leg Ulcer; Home Health Care; Trauma Wound; Home Health Nurse; Arterial Ulcer; Wound Dehiscence; Open Wound
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: CE054ALF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO