Prevention of the Risk of Complete Sternotomy Scar Dehiscence in Cardiac Surgery: A Clinical Investigation Comparing Negative Pressure Wound Therapy (NPWT) vs. Standard Dressing

NCT ID: NCT06207630

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 660 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-08
• Study Completion Date: 2025-08-25

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).

Conditions

Complete Vertical Midline Sternotomy / Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard dressing group

Use dry dressing, made with sterile compresses, then a glued dressing

Group Type: ACTIVE_COMPARATOR

Dressing Device

Intervention Type: DEVICE

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.

NPWT 3/7d dressing group

Use of a PICO® dressing

Group Type: EXPERIMENTAL

Dressing Device

Intervention Type: DEVICE

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.

NPWT 7d dressing group

Use of a PREVENA® dressing

Group Type: EXPERIMENTAL

Dressing Device

Intervention Type: DEVICE

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.

Interventions

Dressing Device

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.

Intervention Type: DEVICE

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

France

References

Jayle C, Allain G, Buono A, Dang Van S, D'Ostrevy N, Kermen S, Picardo A, Pelras A, Drux J, Corbi P, Billot M, Frasca D. Reduction of the risk of complete sternotomy scar dehiscence in cardiac surgery: a protocol for a randomised, open-label multicentre clinical investigation comparing negative pressure wound therapy (NPWT) versus standard dressing (PRISTER study). BMJ Open. 2025 Nov 19;15(11):e104226. doi: 10.1136/bmjopen-2025-104226.

Reference Type: DERIVED

PMID: 41263903 (View on PubMed)

Other Identifiers

PRISTER

Identifier Type: -

Identifier Source: org_study_id