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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03250442
Other study ID # 2017-0599
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date September 2021

Study information

Verified date September 2019
Source Georgetown University
Contact Christopher Attinger, MD
Phone 202-444-8780
Email christopher.attinger@medstar.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 112
Est. completion date September 2021
Est. primary completion date September 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
PrevenaTM Device
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.
Other:
Standard Dry Dressing
These are customary dry dressings.

Locations

Country Name City State
United States Medstar Georgetown University Hospital Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of postoperative incision complications between the 2 arms The proportion of issues that arise between the two groups after closure surgery. 95 days
Secondary Length of hospital stay The amount of time the patients must stay after closure surgery. 5 days
Secondary Number of surgically related wound readmissions The number of times patients are readmitted to the hospital for their surgical wound post-discharge. 95 days
Secondary Medical Outcomes Study 12 Short Form Health Survey (SF-12) Change in quality of life from the start of the study to the end. 95 days
Secondary 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. At 1, 2, and 3 months post-hospital discharge
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