Prevention of Surgical Wound Infection

Maria Jesus Perez

Status: Unknown

Conditions: Cardiac Surgery

Treatments: Device: dressing MEPORE; Device: dressing PICCO; Device: dressing MEPILEX

Study type: Interventional

Funder types: Other

Identifiers

NCT03905213

MICRO.HGUGM.2018-008

Details and patient eligibility

About

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

Full 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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• hypersensibility to dressings

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 3 patient groups

conventional gauze

Active Comparator group

Description:

Device is a conventional gauze and the change will be to the day 2 and 4 of surgery

Treatment:

Device: dressing MEPORE

polyurethane dressing

Experimental group

Description:

Device is a polyurethane dressing and the change will be to the day 7 of surgery

Treatment:

Device: dressing MEPILEX

vacuum therapy dressing

Experimental group

Description:

Device is a vacuum therapy dressing and the change will be to the day 7 of surgery

Treatment:

Device: dressing PICCO