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Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Amputations

Primary Purpose

Surgical Wound, Wound Heal, Amputation

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PrevenaTM Device
Standard Dry Dressing
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Must be at least 18 years or older to participate.
  2. Requires closure of a nontrauamtic Transmetatarsal Amputation (TMA), Below Knee Amputation (BKA), Knee Disarticulation (KD), or Above Knee Amputation (AKA).
  3. Has at least one artery that feeds the closure site.
  4. Able to comply with clinical trial procedures and schedule.

Exclusion Criteria:

  1. Patients not receiving an amputation.
  2. The investigator/provider determines that the patient has an indication against incisional negative pressure wound therapy that would prevent them from participating.
  3. Surgical incision that is not completely closed.

Sites / Locations

  • Medstar Georgetown University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Group A: Standard Dry Dressing

Group B: Foam, Drape, and PrevenaTM

Arm Description

The standard dry dressing is comprised of nonadherent dressing, dry gauze, cotton undercast padding, compression, and immobilization.

This arm is comprised of foam, drape, the PrevenaTM Device, compression, and immobilization.

Outcomes

Primary Outcome Measures

Proportion of postoperative incision complications between the 2 arms
The proportion of issues that arise between the two groups after closure surgery.

Secondary Outcome Measures

Length of hospital stay
The amount of time the patients must stay after closure surgery.
Number of surgically related wound readmissions
The number of times patients are readmitted to the hospital for their surgical wound post-discharge.
Medical Outcomes Study 12 Short Form Health Survey (SF-12)
Change in quality of life from the start of the study to the end.
Percentage of closed incisions remained closed at 1, 2 and 3 months post-hospital discharge
The percentage of closed surgical wounds that remain closed after 1, 2 and 3 months after their closure surgery.

Full Information

First Posted
August 8, 2017
Last Updated
September 24, 2019
Sponsor
Georgetown University
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1. Study Identification

Unique Protocol Identification Number
NCT03250442
Brief Title
Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Amputations
Official Title
A Randomized Controlled Trial Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Lower Extremity Amputations: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgetown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate how well subjects heal after surgery who receive standard dressings or incisional negative pressure wound therapy for non-traumatic amputation sites.
Detailed Description
Incisional negative pressure wound therapy is an approved device used for wound healing of closed surgical incisions. This research is being done because incisional negative pressure wound therapy is a new application of negative pressure wound therapy that is applied over a closed incision area instead of an open wound. Negative pressure wound therapy is commonly used to help heal open wounds. It involves the use of a piece of foam, an adhesive drape, and a battery-powered device that places negative pressure on the wound. Currently, there are no trials utilizing incisional negative pressure wound therapy of closed wounds after below knee amputations (BKA), transmetatarsal amputations (TMA), Knee Disarticulations (KD), and Above Knee Amputations (AKA). This is a pilot study that compares incisional negative pressure wound therapy and standard dressings in patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound, Wound Heal, Amputation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Standard Dry Dressing
Arm Type
Other
Arm Description
The standard dry dressing is comprised of nonadherent dressing, dry gauze, cotton undercast padding, compression, and immobilization.
Arm Title
Group B: Foam, Drape, and PrevenaTM
Arm Type
Active Comparator
Arm Description
This arm is comprised of foam, drape, the PrevenaTM Device, compression, and immobilization.
Intervention Type
Device
Intervention Name(s)
PrevenaTM Device
Intervention Description
The PrevenaTM Incision Management System covers and protects the incision from external contamination, while negative pressure removes fluid and infectious material from the surgical incision.
Intervention Type
Other
Intervention Name(s)
Standard Dry Dressing
Intervention Description
These are customary dry dressings.
Primary Outcome Measure Information:
Title
Proportion of postoperative incision complications between the 2 arms
Description
The proportion of issues that arise between the two groups after closure surgery.
Time Frame
95 days
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
The amount of time the patients must stay after closure surgery.
Time Frame
5 days
Title
Number of surgically related wound readmissions
Description
The number of times patients are readmitted to the hospital for their surgical wound post-discharge.
Time Frame
95 days
Title
Medical Outcomes Study 12 Short Form Health Survey (SF-12)
Description
Change in quality of life from the start of the study to the end.
Time Frame
95 days
Title
Percentage of closed incisions remained closed at 1, 2 and 3 months post-hospital discharge
Description
The percentage of closed surgical wounds that remain closed after 1, 2 and 3 months after their closure surgery.
Time Frame
At 1, 2, and 3 months post-hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Must be at least 18 years or older to participate. Requires closure of a nontrauamtic Transmetatarsal Amputation (TMA), Below Knee Amputation (BKA), Knee Disarticulation (KD), or Above Knee Amputation (AKA). Has at least one artery that feeds the closure site. Able to comply with clinical trial procedures and schedule. Exclusion Criteria: Patients not receiving an amputation. The investigator/provider determines that the patient has an indication against incisional negative pressure wound therapy that would prevent them from participating. Surgical incision that is not completely closed.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Attinger, MD
Phone
202-444-8780
Email
christopher.attinger@medstar.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Attinger, MD
Organizational Affiliation
MedStar Georgetown University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medstar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Kim, DPM
Phone
202-444-3059
First Name & Middle Initial & Last Name & Degree
Paul Kim, DPM

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Amputations

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