Managing Wounds With Allevyn Life in a Home Health Care Environment

Not Applicable

Withdrawn

• Conditions: Wounds and Injuries
• Interventions: Device: Allevyn Life; Device: Foam dressing with an integrated adhesive border

• Registration Number: NCT02776800
• Lead Sponsor: Smith & Nephew, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-16
• Study First Posted: 2016-05-18
• Study Start: 2016-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-08
• Last Update Posted: 2017-02-09
• Primary Completion: 2017-07
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allevyn Life	Allevyn Life	Foam Dressing
Foam Dressing	Foam dressing with an integrated adhesive border	Standard Care - Foam Dressing

Primary Outcome Measures

Name	Time	Method
Number of home health clinician visits in each group	60 days

Secondary Outcome Measures

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