Negative Pressure Wound Therapy vs Standard Care Dressing

Study Overview
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Brief Summary
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A comparison between the efficacy of negative pressure wound therapy and the efficacy of standard care dressing

Detailed Description
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The aim of our study is to compare the efficacy of negative pressure wound therapy (Prevena) and standard clinical dressing in terms of prevention of postoperative surgical site infection, length of hospital stay, and total cost of hospitalization among vascular, plastic and general surgery patients.

Official Title
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A Comparison of Negative Pressure Wound Therapy vs Standard Care, for Vascular, Plastic and General Surgery

Conditions
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Negative-Pressure Wound Therapy

Intervention / Treatment
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* Device: Negative pressure wound therapy
* Other: standard care dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consent for participation from the patient or his legal representative Exclusion Criteria: Currently infected wounds Patients with history of immunosupression Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Interventional Model Description: Comparing the rate of occurrence of surgical site infection, total hospital cost and length of stay between two groups: group 1 represents patients who receive Prevena for postoperative wound care and group 2 represents patients who receive standard care dressing for the same purpose.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Negative pressure wound therapy<br>This group of patients will receive negative pressure wound therapy (prevena) as their postoperative wound care method. | Device: Negative pressure wound therapy<br>* The application of a vacuum across the surface of a wound through a foam dressing cut to fit the wound.<br>* Other names: Prevena;|
| Active Comparator: standard care dressing<br>This group of patients will receive standard care dressing as their postoperative wound care method. | Other: standard care dressing<br>* The application of a standard care dressing (instead of negative pressure wound therapy) across the surface of wound.<br>* Other names: dray gauze;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection | The rate of occurrence of signs and symptoms of surgical site infection | 30-day postoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of total hospital stay | number of days of patients hospital stay after the surgery | 6 months | 
| cost of hospitalization | The total cost in USD of patient's hospitalization | 6 months | 
| Rate of reoperation | The rate of patients' re-operation after the principal operation | 30-day postoperative period |