Managing Wounds With Allevyn Life in a Home Health Care Environment

NCT02776800 | Withdrawn

• 1 other identifier: CE054ALF
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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

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

Outcome Measures

Primary Outcomes (1)

• Number of home health clinician visits in each group

  60 days

Secondary Outcomes (5)

• 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

Study Arms (2)

Allevyn Life

EXPERIMENTAL

Foam Dressing

Device: Allevyn Life

Foam Dressing

OTHER

Standard Care - Foam Dressing

Device: Foam dressing with an integrated adhesive border

Interventions

Allevyn Life DEVICE

Allevyn Life

Foam dressing with an integrated adhesive border DEVICE

Foam dressing normally used by the home health agency

Foam Dressing

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \. 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.
• \. Willing and able to allow home health clinician to conduct all required study visits.
• \. 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.
• \. 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.
• \. At Screening, wound exudate must be moderate to heavy, as determined by the home health clinician.
• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (3)

Unknown Facility

Tustin, California, 92780, United States

Location

Unknown Facility

Wichita, Kansas, 67203, United States

Location

Unknown Facility

McAllen, Texas, 78501, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Surgical Wound; Pressure Ulcer; Diabetic Foot; Varicose Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Study Officials

• Herbert B Slade, MD

  Smith & Nephew, Inc.

  STUDY CHAIR

• Jaime E Dickerson, PhD

  Smith & Nephew, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 18, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: October 1, 2017
• Last Updated: February 9, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)