Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Group A: Standard Dry Dressing
The standard dry dressing is comprised of nonadherent dressing, dry gauze, cotton undercast padding, compression, and immobilization.
  • Other: Standard Dry Dressing
    These are customary dry dressings.
Active Comparator
Group B: Foam, Drape, and PrevenaTM
This arm is comprised of foam, drape, the PrevenaTM Device, compression, and immobilization.
  • 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.

Recruiting Locations

Medstar Georgetown University Hospital
Washington, District of Columbia 20007
Contact:
Paul Kim, DPM
202-444-3059

More Details

Status
Unknown status
Sponsor
Georgetown University

Study Contact

Christopher Attinger, MD
202-444-8780
christopher.attinger@medstar.net

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.