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
1 other identifier
interventional
900
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2019
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2019
CompletedFirst Posted
Study publicly available on registry
April 5, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2021
CompletedJuly 1, 2019
March 1, 2019
2 years
March 20, 2019
June 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
prevention of surgical wound infection
surgical wound infection measured as number of patients suffering surgical wound infection during the study period
surgery date up to 6 months
Secondary Outcomes (3)
hospital stay
from hospitalization until an average of 1 year
antimicrobial consumption
from surgery date until an average of 1 year
dressing consumption cost
from surgery date until an average of 8 weeks
Study Arms (3)
conventional gauze
ACTIVE COMPARATORDevice is a conventional gauze and the change will be to the day 2 and 4 of surgery
polyurethane dressing
EXPERIMENTALDevice is a polyurethane dressing and the change will be to the day 7 of surgery
vacuum therapy dressing
EXPERIMENTALDevice is a vacuum therapy dressing and the change will be to the day 7 of surgery
Interventions
assignation to three different authorised and on label dressing: conventional dressing (MEPORE)
assignation to three different authorised and on label dressing: absorbent(MEPILEX)
assignation to three different authorised and on label dressing:vacuum Therapy dressing(PICCO)
Eligibility Criteria
You may qualify if:
- patient scheduled to cardiac surgery.
- signed informed consent form
You may not qualify if:
- hypersensibility to dressings
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maria Jesus Perezlead
- Instituto de Salud Carlos IIIcollaborator
Related Publications (1)
Perez-Granda MJ, Cuerpo G, Barrio JM, Valerio M, Munoz P, Pinto AG, Valencia DE, Vicario FS, Bouza E; Cardiovascular Infection Study Group. A prospective randomized study that compares three different dressings for the prevention of surgical site infections following major heart surgery. Sci Rep. 2025 Jun 6;15(1):19960. doi: 10.1038/s41598-025-02533-7.
PMID: 40481025DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Jesus Perez Granda, PhD
Gregorio Marañón Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 20, 2019
First Posted
April 5, 2019
Study Start
September 1, 2019
Primary Completion
August 28, 2021
Study Completion
August 28, 2021
Last Updated
July 1, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share