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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
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.
These are customary dry dressings.
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
RECRUITINGProportion of postoperative incision complications between the 2 arms
The proportion of issues that arise between the two groups after closure surgery.
Time frame: 95 days
Length of hospital stay
The amount of time the patients must stay after closure surgery.
Time frame: 5 days
Number of surgically related wound readmissions
The number of times patients are readmitted to the hospital for their surgical wound post-discharge.
Time frame: 95 days
Medical Outcomes Study 12 Short Form Health Survey (SF-12)
Change in quality of life from the start of the study to the end.
Time frame: 95 days
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.
Time frame: At 1, 2, and 3 months post-hospital discharge
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