- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03905213
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
|
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
|
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
|
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
Collaborators
Investigators
- Principal Investigator: Maria Jesus Perez Granda, PhD, Gregorio Marañón 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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