VAC NPWT KCI Dressing Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-10-31

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.

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Detailed Description

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No further description is desired

Conditions

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Surgical Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Dry Dressing

Incisions that were dressed with a sterile dry dressing at end of operation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Negative Pressure Wound Therapy

Incisions dressed with a V.A.C. (NPWT) postoperatively.

Group Type EXPERIMENTAL

V.A.C. by K.C.I.

Intervention Type DEVICE

Negative Pressure Wound Therapy, Delivered by Vacuum Assisted Closure (KCI) across closed surgical incision at completion of surgery

Interventions

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V.A.C. by K.C.I.

Negative Pressure Wound Therapy, Delivered by Vacuum Assisted Closure (KCI) across closed surgical incision at completion of surgery

Intervention Type DEVICE

Other Intervention Names

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V.A.C. (Kinetic Concepts Incorporate)

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