Prevention of Surgical Wound Infection

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03905213

Enrollment

900

Registered

2019-04-05

Start date

2019-09-01

Completion date

2021-08-28

Last updated

2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

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.

Interventions

DEVICEdressing MEPORE

assignation to three different authorised and on label dressing: conventional dressing (MEPORE)

DEVICEdressing MEPILEX

assignation to three different authorised and on label dressing: absorbent(MEPILEX)

DEVICEdressing PICCO

assignation to three different authorised and on label dressing:vacuum Therapy dressing(PICCO)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

randomized in three groups

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* hypersensibility to dressings

Design outcomes

Primary

Measure	Time frame	Description
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

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

Contacts

Primary ContactMaria Jesus Perez Granda, PhD

massus@hotmail.es+34618355299

Backup Contactfrancisco Javier Hortal, PhD

javier.hortal@gamil.com+34915868377

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026