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Managing Wounds With Allevyn Life in a Home Health Care Environment

Primary Purpose

Wounds and Injuries

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Allevyn Life

Foam dressing with an integrated adhesive border

About this trial

This is an interventional supportive care trial for Wounds and Injuries focused on measuring 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

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Allevyn Life

Foam Dressing

Arm Description

Foam Dressing

Standard Care - Foam Dressing

Outcomes

Primary Outcome Measures

Number of home health clinician visits in each group

Secondary Outcome Measures

Home health provider time on-site

Total cost of each treatment group

Number of visits required compared to number initially anticipated

Assess the Cardiff Wound Impact Schedule

Average dressing wear time

Full Information

NCT ID

NCT02776800

First Posted

May 16, 2016

Last Updated

February 8, 2017

Sponsor

Smith & Nephew, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02776800

Brief Title

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

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Business Decision

Study Start Date

August 2016 (Anticipated)

Primary Completion Date

July 2017 (Anticipated)

Study Completion Date

October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Smith & Nephew, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Allevyn Life

Arm Type

Experimental

Arm Description

Foam Dressing

Arm Title

Foam Dressing

Arm Type

Other

Arm Description

Standard Care - Foam Dressing

Intervention Type

Device

Intervention Name(s)

Allevyn Life

Intervention Type

Device

Intervention Name(s)

Foam dressing with an integrated adhesive border

Intervention Description

Foam dressing normally used by the home health agency

Primary Outcome Measure Information:

Title

Number of home health clinician visits in each group

Time Frame

60 days

Secondary Outcome Measure Information:

Title

Home health provider time on-site

Time Frame

60 days

Title

Total cost of each treatment group

Time Frame

60 days

Title

Number of visits required compared to number initially anticipated

Time Frame

60 days

Title

Assess the Cardiff Wound Impact Schedule

Time Frame

60 days

Title

Average dressing wear time

Time Frame

60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Herbert B Slade, MD

Organizational Affiliation

Smith & Nephew, Inc.

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jaime E Dickerson, PhD

Organizational Affiliation

Smith & Nephew, Inc.

Official's Role

Study Director

Facility Information:

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67203

Country

United States

City

McAllen

State/Province

Texas

ZIP/Postal Code

78501

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Managing Wounds With Allevyn Life in a Home Health Care Environment

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