Prevention of Surgical Wound Infection

June 28, 2019 updated by: Maria Jesus Perez

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • hypersensibility to dressings

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevention of surgical wound infection
Time Frame: surgery date up to 6 months
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
Time Frame: from hospitalization until an average of 1 year
days at hospital
from hospitalization until an average of 1 year
antimicrobial consumption
Time Frame: from surgery date until an average of 1 year
defined dose of antimicrobial agents during hospital stay
from surgery date until an average of 1 year
dressing consumption cost
Time Frame: from surgery date until an average of 8 weeks
number of dressing and its cost
from surgery date until an average of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Jesus Perez

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Maria Jesus Perez Granda, PhD, Gregorio Maranon Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

August 28, 2021

Study Completion (Anticipated)

August 28, 2021

Study Registration Dates

First Submitted

March 20, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (Actual)

April 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 1, 2019

Last Update Submitted That Met QC Criteria

June 28, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MICRO.HGUGM.2018-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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