Prevention of Surgical Wound Infection

Not Applicable

• Conditions: Cardiac Surgery
• Interventions: Device: dressing MEPORE; Device: dressing PICCO; Device: dressing MEPILEX

• Registration Number: NCT03905213
• Lead Sponsor: Maria Jesus Perez

Brief Summary

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

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.

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-04-03
• Study First Posted: 2019-04-05
• Last Update Submitted: 2019-06-28
• Last Update Posted: 2019-07-01
• Study Start: 2019-09-01
• Primary Completion: 2021-08-28
• Study Completion: 2021-08-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• patient scheduled to cardiac surgery.
• signed informed consent form

Exclusion Criteria

• hypersensibility to dressings

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional gauze	dressing MEPORE	Device is a conventional gauze and the change will be to the day 2 and 4 of surgery
vacuum therapy dressing	dressing PICCO	Device is a vacuum therapy dressing and the change will be to the day 7 of surgery
polyurethane dressing	dressing MEPILEX	Device is a polyurethane dressing and the change will be to the day 7 of surgery

Primary Outcome Measures

Name	Time	Method
prevention of surgical wound infection	surgery date up to 6 months	surgical wound infection measured as number of patients suffering surgical wound infection during the study period

Secondary Outcome Measures

Name	Time	Method
hospital stay	from hospitalization until an average of 1 year	days at hospital
dressing consumption cost	from surgery date until an average of 8 weeks	number of dressing and its cost
antimicrobial consumption	from surgery date until an average of 1 year	defined dose of antimicrobial agents during hospital stay