VAC NPWT KCI Dressing Study

Study Overview
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Brief Summary
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In this study, the investigators propose using negative pressure wound therapy (NPWT) to aid in wound healing along the lines of closure for lower extremity amputation and complex abdominal wounds. This study is designed to be a prospective, randomized clinical trial to evaluate the effectiveness of NPWT versus accepted standard surgical dressings on these wounds. Study participants will be randomized to one of the two treatment groups (NPWT vs. standard dressing) prior to surgery, and will be followed in the post operative period to monitor the effects on their surgical closures. The experimental group will consist of participants receiving NPWT and will have a Vacuum Assisted Closure (V.A.C., KCI inc.) device placed intra-op along the line of closure. The control group will receive a standard surgical dry sterile dressing. The surgical closures will be assessed after three days of treatment as well as the first outpatient post-op visit and any subsequent visits through the following 6 months. By doing so, the investigators hope to demonstrate the utility of NPWT on difficult, at risk surgical closures. Additionally, the investigators hope to show a difference in clinical outcome of incisions treated by NPWT over our current standard technique. All patients in the principal and co-investigators practice who are scheduled to undergo lower extremity amputation or complex abdominal closure will be eligible for enrollment in this prospective randomized study. There are no exclusion criteria. Informed consent will be obtained pre-operatively. Data collection will include basic demographic data, disease history, past medical and social history as well key data relating to wound healing (infection, wound dehiscence or breakdown) and hospital course (length of stay, operative complications). The investigators will use simple statistical methods (ANOVA and chi-squared analysis) to compare surgical wound healing between the two populations. The only deviation from current standard of care in these populations includes utilizing a V.A.C. system on the closure line of the experimental group versus the standard dry sterile dressing.

Detailed Description
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No further description is desired

Official Title
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Use of Negative Pressure Wound Therapy for At Risk Surgical Closures

Conditions
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Surgical Wound Infection

Intervention / Treatment
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* Device: V.A.C. by K.C.I.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients presenting to wound center undergoing wound treatment with expected closure of wounds including: Midfoot amputations, below knee amputations, knee disarticulations, above knee amputations, and trunk wounds wounds must be closed primarily without the use of grafts Exclusion Criteria: any patient <18 years old any patient whose wound is unable to be closed primarily

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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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Dry Dressing<br>Incisions that were dressed with a sterile dry dressing at end of operation. | |
| Experimental: Negative Pressure Wound Therapy<br>Incisions dressed with a V.A.C. (NPWT) postoperatively. | Device: V.A.C. by K.C.I.<br>* Negative Pressure Wound Therapy, Delivered by Vacuum Assisted Closure (KCI) across closed surgical incision at completion of surgery<br>* Other names: V.A.C. (Kinetic Concepts Incorporate);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional Dehiscence | any amount of incisional dehiscence noted post-operatively | last post operative visit, up to 2 years | 
| Post operative infection | Post operative infection as noted by increased white count, clinical findings supporting infection (erythema, purulence, wound drainage) | last post operative visit, up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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V.A.C., Wound healing, Negative Pressure Wound Therapy, Incision