Amputation, Surgical Wound, Wound Heal
Conditions
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.
Interventions
DEVICEPrevenaTM 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.
OTHERStandard Dry Dressing
These are customary dry dressings.
Sponsors
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of postoperative incision complications between the 2 arms | 95 days | The proportion of issues that arise between the two groups after closure surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | 5 days | The amount of time the patients must stay after closure surgery. |
| Number of surgically related wound readmissions | 95 days | The number of times patients are readmitted to the hospital for their surgical wound post-discharge. |
| Medical Outcomes Study 12 Short Form Health Survey (SF-12) | 95 days | Change in quality of life from the start of the study to the end. |
| Percentage of closed incisions remained closed at 1, 2 and 3 months post-hospital discharge | 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. |
Countries
United States
Contacts
Primary ContactChristopher Attinger, MD
Outcome results
None listed