Back to resultsPrevention of Surgical Wound Infection
Primary Purpose
Cardiac Surgery
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
dressing MEPORE
dressing MEPILEX
dressing PICCO
Sponsored by
About this trial
This is an interventional prevention trial for Cardiac Surgery
Eligibility Criteria
Inclusion Criteria:
- patient scheduled to cardiac surgery.
- signed informed consent form
Exclusion Criteria:
- hypersensibility to dressings
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
conventional gauze
polyurethane dressing
vacuum therapy dressing
Arm Description
Device is a conventional gauze and the change will be to the day 2 and 4 of surgery
Device is a polyurethane dressing and the change will be to the day 7 of surgery
Device is a vacuum therapy dressing and the change will be to the day 7 of surgery
Outcomes
Primary Outcome Measures
prevention of surgical wound infection
surgical wound infection measured as number of patients suffering surgical wound infection during the study period
Secondary Outcome Measures
hospital stay
days at hospital
antimicrobial consumption
defined dose of antimicrobial agents during hospital stay
dressing consumption cost
number of dressing and its cost
Full Information
NCT ID
NCT03905213
First Posted
March 20, 2019
Last Updated
June 28, 2019
Sponsor
Maria Jesus Perez
Collaborators
Instituto de Salud Carlos III
1. Study Identification
Unique Protocol Identification Number
NCT03905213
Brief Title
Prevention of Surgical Wound Infection
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
August 28, 2021 (Anticipated)
Study Completion Date
August 28, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maria Jesus Perez
Collaborators
Instituto de Salud Carlos III
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized in three groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional gauze
Arm Type
Active Comparator
Arm Description
Device is a conventional gauze and the change will be to the day 2 and 4 of surgery
Arm Title
polyurethane dressing
Arm Type
Experimental
Arm Description
Device is a polyurethane dressing and the change will be to the day 7 of surgery
Arm Title
vacuum therapy dressing
Arm Type
Experimental
Arm Description
Device is a vacuum therapy dressing and the change will be to the day 7 of surgery
Intervention Type
Device
Intervention Name(s)
dressing MEPORE
Intervention Description
assignation to three different authorised and on label dressing: conventional dressing (MEPORE)
Intervention Type
Device
Intervention Name(s)
dressing MEPILEX
Intervention Description
assignation to three different authorised and on label dressing: absorbent(MEPILEX)
Intervention Type
Device
Intervention Name(s)
dressing PICCO
Intervention Description
assignation to three different authorised and on label dressing:vacuum Therapy dressing(PICCO)
Primary Outcome Measure Information:
Title
prevention of surgical wound infection
Description
surgical wound infection measured as number of patients suffering surgical wound infection during the study period
Time Frame
surgery date up to 6 months
Secondary Outcome Measure Information:
Title
hospital stay
Description
days at hospital
Time Frame
from hospitalization until an average of 1 year
Title
antimicrobial consumption
Description
defined dose of antimicrobial agents during hospital stay
Time Frame
from surgery date until an average of 1 year
Title
dressing consumption cost
Description
number of dressing and its cost
Time Frame
from surgery date until an average of 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient scheduled to cardiac surgery.
signed informed consent form
Exclusion Criteria:
hypersensibility to dressings
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Jesus Perez Granda, PhD
Phone
+34618355299
Email
massus@hotmail.es
First Name & Middle Initial & Last Name or Official Title & Degree
francisco Javier Hortal, PhD
Phone
+34915868377
Email
javier.hortal@gamil.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Jesus Perez Granda, PhD
Organizational Affiliation
Gregorio Marañón Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prevention of Surgical Wound Infection
We'll reach out to this number within 24 hrs