Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Amputations

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Lower Extremity Amputations: A Pilot Study

Conditions
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Surgical Wound, Wound Heal, Amputation

Intervention / Treatment
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* Device: PrevenaTM Device
* Other: Standard Dry Dressing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A: Standard Dry Dressing<br>The standard dry dressing is comprised of nonadherent dressing, dry gauze, cotton undercast padding, compression, and immobilization. | Other: Standard Dry Dressing<br>* These are customary dry dressings.<br>|
| Active Comparator: Group B: Foam, Drape, and PrevenaTM<br>This arm is comprised of foam, drape, the PrevenaTM Device, compression, and immobilization. | Device: PrevenaTM Device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of postoperative incision complications between the 2 arms | The proportion of issues that arise between the two groups after closure surgery. | 95 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | The amount of time the patients must stay after closure surgery. | 5 days | 
| Number of surgically related wound readmissions | The number of times patients are readmitted to the hospital for their surgical wound post-discharge. | 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. | 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. | At 1, 2, and 3 months post-hospital discharge |