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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
660
Use of a dress at the end of surgery in the operating room, making sure not to stick it on the openings of the chest drains.
C.H.U. of Angers
Angers, France
C.H.U. of Clermont-Ferrand
Clermont-Ferrand, France
C.H.U. of Limoges
Limoges, France
C.H.U. of Poitiers
Poitiers, France
C.H.U. Tours
Tours, France
Complete median sternotomy wound cutaneous dehiscence
Complete median sternotomy wound cutaneous dehiscence in cardiac surgery during the first 30 postoperative days will be assessed by tablet calibrated photos analyzed by an independent blinded staff.
Time frame: 30 postoperative days
The number of dressing repairs
Time frame: Between 7 and 90 postoperative days
The length of initial hospital stay
Time frame: Between 7 and 90 postoperative days
The occurrence of an infection of the surgical site and its classification
Time frame: At Day 90
The use of an anti-infectious treatment and its duration.
Time frame: Between 7 and 90 postoperative days
The incidence of postoperative mediastinitis defined by dehiscence of the sternum with positive sternal samples.
Time frame: At Day 90
The incidence of surgical revision for dehiscence of the surgical wound at D90.
Collection of all operations involving surgical revision of the sternotomy wound.
Time frame: At Day 90
The number of rehospitalizations (including consultations), and their duration.
Time frame: At Day 90
The nurse's satisfaction with the use of the 3 types of dressing during dressing repair by means of a standardized questionnaire.
The nurse's satisfaction with the use of the 3 types of dressing during dressing repair by means of a standardized questionnaire consisting in four questions rated from 1 (not satisfied) to 5 (totally satisfied): Are you satisfied with application of this dressing? Are you satisfied with management of the surgical wound? Are you satisfied with follow-up on the wound? Are you satisfied with the visual appearance of the surgical wound?
Time frame: 7 postoperative days
The surgeon's satisfaction with the wound by means of a standardized questionnaire.
The surgeon's satisfaction with the wound by means of a standardized questionnaire consisting in four questions rated from 1 (not satisfied) to 5 (totally satisfied): Are you satisfied with application of this dressing? Are you satisfied with management of the surgical wound? Are you satisfied with follow-up on the wound? Are you satisfied with the visual appearance of the surgical wound? .
Time frame: 7 postoperative days
The incremental cost-utility ratio expressed in costs per quality-adjusted life-year (QALY) gained.
Medico-economic assessment will be assessed by evaluation of hospital and extra-hospital costs (number of days in hospital, consultations, re-hospitalisations, imaging, biology and drugs), dressing costs and patient quality of life by EQ-5D-5L. The proposed analysis will be a cost-utility analysis because health-related quality of life is a significant outcome of the studied interventions.
Time frame: Between 7 and 90 postoperative days
The incremental cost-effectiveness ratio expressed in costs per post-operative complication avoided
Resource utilization data will be collected prospectively for all patients enrolled in the clinical investigation. The collected metrics will include costs associated with initial hospitalization, surgical duration, devices utilized during the procedure, length of stay, and readmissions.
Time frame: Between 7 and 90 postoperative days
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