Negative Pressure Wound Therapy for the Prevention of Surgical Site Infection Following Lower Limb Revascularization

Study Overview
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Brief Summary
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The purpose of this study is to investigate the current standard of wound care following vascular operations compared to to a negative pressure wound therapy (vacuum dressing) and the rate of surgical site infections (SSIs) in patients undergoing surgery to restore blood flow to the lower limb(s). Negative pressure wound therapy consists of a closed, sealed system that produces negative pressure (vacuum) to the wound surface. The device itself consists of open-cell foam that is sealed with an occlusive adhesive dressing (covers and sticks to the incision) and suction is maintained by connecting suction tubes to a vacuum pump and waste collector. The investigators objectives are to determine whether there will be any reduction in surgical site infection and this potential reduction will influence length of hospital stay, emergency room visits, antibiotic use and need for re-operation.

Detailed Description
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The study is a non-blinded randomized control trial. The study examines the effect on wound healing and surgical site infection using negative pressure wound therapy compared to standard dressing in high-risk patients (BMI > 30, previous femoral cut-down). The investigators expected to find a lower surgical site infection rate in patients using the NPWT device. Patients after giving informed consent will be randomized to receive either NPWT or standard wound therapy following tier lower-limb revascularization operative. Both will be applied under sterile conditions immediately post-operatively. The intervention will be left for 4-7 days depending on the discharge date and the standard dressing will be removed on post-operative day two. The data will be analyzed with an intention to treat analysis.

Official Title
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Single Center Prospective Randomized Control Trial on Negative Pressure Wound Therapy for Primarily Closed Groin Incisions Following Lower-limb Re-vascularization to Reduce Surgical Site Infection

Conditions
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Surgical Wound Infection, Peripheral Vascular Diseases

Intervention / Treatment
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* Device: Prevena (Negative Pressure Wound Therapy Device)
* Device: Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI > 35 Previous femoral exposure Undergoing lower-limb revascularization Exclusion Criteria: Cannot obtain seal Non-primary wound closure Pre-existing infection Endovascular repair

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Current Standard<br>Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing applied under sterile conditions in the operating room following skin closure. Dressing changed post-operative day two and daily thereafter with daily inspection for infection by a physician. | Device: Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing<br> <br> |
| Experimental: Negative Pressure Wound Therapy<br>A negative pressure therapy (Kinetic Concepts, Inc, San Antionio, Tex) device will be applied under sterile conditions post-operatively and placed on suction (125-150 cm H2O). The device will be removed on post-operative day 4-7 depending on day of discharge. | Device: Prevena (Negative Pressure Wound Therapy Device)<br>* No other details required.<br>* Other names: Vacuum Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site Infection | Surgical site infection is defined by the CDC Guidelines for surgical site infection and by the Szilagyi classification of vascular wound infections. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Duration (in days) the patient stays in hospital post-operatively | Date of discharge | 
| Emergency room visits | Number of times the patient return to the emergency department following discharge from hospital and before the follow-up clinic appointment | 30 days | 
| All-cause mortality |  | 30 days | 
| Re-operation rate | Need for re-operation following graft failure secondary to infection | 30 days | 
| Amputation | Need for amputation post-operatively secondary to infection | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical Site Infection, Vascular Surgery, Negative Pressure Wound Therapy