Recruiting

Negative Pressure

Sponsor:

Georgetown University

Code:

NCT03250442

Conditions

Surgical Wound

Wound Heal

Amputation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

PrevenaTM Device

Standard Dry Dressing

Study Details

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.

Conditions

Surgical Wound

Wound Heal

Amputation

Study ID

NCT03250442

Start date

Nov 1, 2017

Status verified date

Sep, 2019

Completion date

Sep, 2021

Anticipated

Primary completion date

Sep, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

112 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Group A: Standard Dry Dressing

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

active comparator: Group B: Foam, Drape, and PrevenaTM

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

Interventions

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.

Standard Dry Dressing

These are customary dry dressings.

Primary outcome measure

  • Proportion of postoperative incision complications between the 2 arms [ Time Frame: 95 days ]

Central Contacts and Locations

Central contacts

Christopher Attinger, MD

202-444-8780christopher.attinger@medstar.net

Locations

Medstar Georgetown University Hospital

Recruiting

Washington, District of Columbia, United States, 20007

Contacts

Paul Kim, DPM

202-444-3059

Principal Investigator:

Paul Kim, DPM

More Information

Sponsor

Georgetown University

Last update posted

Sep 25, 2019

Last verified

Sep, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2019-09-25.