Prevention of Surgical Wound Infection

Study Overview
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Brief Summary
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To compare cost effectiveness of a polyurethane dressing or a vacuum therapy dressing versus the conventional gauze in the prevention of superficial wound infection y major cardiac surgery

Detailed Description
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It is a clinical prospective and randomized study. patientes will be randomized to three groups on the day of surgery: conventional gauze, polyurethane or vacuum therapy dressing. Clinical al microbiological data will be monitorized to evaluate the infection rate of surgical wound , mediastinitis, days of hospital stay and consumption of antimicrobials.

Official Title
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Impact of the Use of Three Dressings in the Prevention of Surgical Wound Infection in Patients Undergoing Mayor Cardiac Surgery: a Clinical Prospective and Randomized Study

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Device: dressing MEPORE
* Device: dressing MEPILEX
* Device: dressing PICCO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient scheduled to cardiac surgery. signed informed consent form Exclusion Criteria: hypersensibility to dressings

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
Interventional Model Description: randomized in three groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional gauze<br>Device is a conventional gauze and the change will be to the day 2 and 4 of surgery | Device: dressing MEPORE<br>* assignation to three different authorised and on label dressing: conventional dressing (MEPORE)<br>|
| Experimental: polyurethane dressing<br>Device is a polyurethane dressing and the change will be to the day 7 of surgery | Device: dressing MEPILEX<br>* assignation to three different authorised and on label dressing: absorbent(MEPILEX)<br>|
| Experimental: vacuum therapy dressing<br>Device is a vacuum therapy dressing and the change will be to the day 7 of surgery | Device: dressing PICCO<br>* assignation to three different authorised and on label dressing:vacuum Therapy dressing(PICCO)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevention of surgical wound infection | surgical wound infection measured as number of patients suffering surgical wound infection during the study period | surgery date up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital stay | days at hospital | from hospitalization until an average of 1 year | 
| antimicrobial consumption | defined dose of antimicrobial agents during hospital stay | from surgery date until an average of 1 year | 
| dressing consumption cost | number of dressing and its cost | from surgery date until an average of 8 weeks |