Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Amputations
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
- Surgical Wound
- Wound Heal
- Amputation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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
- 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
Arm | Description | Assigned Intervention |
---|---|---|
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. |
|
Recruiting Locations
Washington, District of Columbia 20007
Paul Kim, DPM
202-444-3059
More Details
- Status
- Unknown status
- Sponsor
- Georgetown University
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.