Status:
COMPLETED
Prevention of the Risk of Complete Sternotomy Scar Dehiscence in Cardiac Surgery: A Clinical Investigation Comparing Negative Pressure Wound Therapy (NPWT) vs. Standard Dressing
Lead Sponsor:
Poitiers University Hospital
Conditions:
Complete Vertical Midline Sternotomy / Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Mediastinitis is the most feared infectious complication after cardiac surgery. Several risk factors are known such as: obesity, diabetes, chronic obstructive pulmonary disease, double breast sampling...
Eligibility Criteria
Inclusion
- All patients undergoing scheduled or semi-urgent cardiac surgery, with or without extracorporeal circulation.
- Patients managed by complete vertical median sternotomy.
- Patients benefiting from a Social Security scheme or benefiting from it through a third party.
- Informed consent signed by the patient after clear and complete information about the clinical investigation.
- All patients included in this clinical investigation must not have any of the non-inclusion criteria listed below:
Exclusion
- Known allergy to one of the dressings: PREVENA®, PICO® or standard dressing
- Patient with a contraindication to PICO® dressing
- Patient with a contraindication to PREVENA® dressing:
- Sensitivity to silver
- Patient with a history of cardiac surgery prior to inclusion
- Patient with skin infection (folliculitis) of the sternotomy site before the operation.
- Urgency and extreme urgency (patient operated within 24 hours of admission).
- Patient already participating in a clinical investigation whose main objective or secondary objectives are likely to have an impact on the main objective of this clinical investigation
- Patient with antibiotherapy ongoing (endocarditis patients)
- Minimal sternotomy (8-10 cm)
- Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy), or having a positive pregnancy test at inclusion
- The inability of the patient to complete informed consent before any study procedure
- Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection
Key Trial Info
Start Date :
March 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2025
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT06207630
Start Date
March 8 2024
End Date
August 25 2025
Last Update
December 10 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
C.H.U. of Angers
Angers, France, 49933
2
C.H.U. of Clermont-Ferrand
Clermont-Ferrand, France, 63000
3
C.H.U. of Limoges
Limoges, France, 87042
4
C.H.U. of Poitiers
Poitiers, France, 86000