A Randomized Controlled Trial Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Lower Extremity Amputations: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Georgetown University
- Enrollment
- 112
- Locations
- 2
- Primary Endpoint
- Proportion of postoperative incision complications between the 2 arms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Group A: Standard Dry Dressing
The standard dry dressing is comprised of nonadherent dressing, dry gauze, cotton undercast padding, compression, and immobilization.
Intervention: Standard Dry Dressing (Other)
Group B: Foam, Drape, and PrevenaTM
This arm is comprised of foam, drape, the PrevenaTM Device, compression, and immobilization.
Intervention: PrevenaTM Device (Device)
Outcomes
Primary Outcomes
Proportion of postoperative incision complications between the 2 arms
Time Frame: 95 days
The proportion of issues that arise between the two groups after closure surgery.
Secondary Outcomes
- Length of hospital stay(5 days)
- Number of surgically related wound readmissions(95 days)
- Percentage of closed incisions remained closed at 1, 2 and 3 months post-hospital discharge(At 1, 2, and 3 months post-hospital discharge)
- Medical Outcomes Study 12 Short Form Health Survey (SF-12)(95 days)
Investigators
Christopher Attinger, M.D.
Associate Professor
Georgetown University