Clinical trial NCT06207630: Prevention of the Risk of Complete Sternotomy Scar Dehiscence in Cardiac Surgery: A Clinical Investigation Comparing Negative Pressure Wound Therapy (NPWT) vs. Standard Dressing
Official title: Prevention of the Risk of Complete Sternotomy Scar Dehiscence in Cardiac Surgery: A Randomized, Open-label Multicenter Clinical Investigation Comparing Negative Pressure Wound Therapy (NPWT) vs. Standard Dressing
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Complete Vertical Midline Sternotomy / Cardiac Surgery
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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, immunodeficiency, corticosteroid therapy, reoperation, chest radiotherapy, and dialysis. Three modes of contamination are described: intraoperative contamination, hematogenous dissemination during sepsis, gradual contamination from cutaneous dehiscence. It is important and simple to fight against this third mode. The dehiscence of the sternotomy scar represents a gateway and facilitates bacterial colonization and is a risk factor for infection of the surgical site. These skin disunities lead to an increase in health care costs due to extension of hospital stay, the cost of repeated nursing care, surgical revision, and the need for increased follow-up. They delay cardiac rehabilitation and return home. It is estimated that these simple disunities occur in more than 15% of cases, although fortunately they rarely result in mediastinitis. While the use of NPWT for the prevention of wound healing complications is permitted, its benefit has not been demonstrated. Its action is multiple with a reduction in the rate of repair of dressings and therefore of soiling, drainage of the wound, limitation of maceration, acceleration of healing. The use of NPWT as a dressing for sternotomies could prevent skin breakdown, and therefore superficial and deep surgical site infections.

Two types of NPWT devices exist, corresponding to 2 different types of treatment: the 7-day NPWT without dressing repair but with reservoir (PREVENA®), the NPWT with 3-day repair without reservoir (PICO®).

Given the cost and widespread use of NPWT for chirurgical site infection prophylaxis, it is important to conduct randomized trials to assess the expected benefit of these NPWTs designed for use on clean, closed surgical incisions. In cardiac surgery, its benefit has only been shown in a high-risk population: surgery for Coronary Artery Bypass Graft (CABG).

The present clinical investigation will be the first randomized, multicenter trial comparing the efficacy and safety of NPWT versus standard dressing in preventing the risk of scar dehiscence after cardiac surgery, in a standard population.

The patients will be followed for 90 days (3 months).


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Complete median sternotomy wound cutaneous dehiscence
timeFrame: 30 postoperative days
Secondary outcomes:
measure: Complete median sternotomy wound cutaneous dehiscence
timeFrame: 7 and 90 postoperative days
measure: The number of dressing repairs
timeFrame: Between 7 and 90 postoperative days
measure: The length of initial hospital stay
timeFrame: Between 7 and 90 postoperative days
measure: The occurrence of an infection of the surgical site and its classification
timeFrame: Between 7 and 90 postoperative days
measure: The use of an anti-infectious treatment and its duration
timeFrame: Between 7 and 90 postoperative days
Other outcomes:
Locations:
city: Angers
country: France
facility: C.H.U. of Angers
city: Clermont-Ferrand
country: France
facility: C.H.U. of Clermont-Ferrand
city: Limoges
country: France
facility: C.H.U. of Limoges
city: Poitiers
country: France
facility: C.H.U. of Poitiers
city: Tours
country: France
facility: C.H.U. Tours
Study officials:
References: