Complete Vertical Midline Sternotomy / Cardiac SurgeryPRISTERNCT06207630
Prevention of the Risk of Complete Sternotomy Scar Dehiscence in Cardiac Surgery: A Clinical Investigation Comparing Negative Pressure Wound Therapy (NPWT) vs. Standard Dressing
A study testing Dressing Device in people with Complete Vertical Midline Sternotomy / Cardiac Surgery, run by Poitiers University Hospital at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complete Vertical Midline Sternotomy / Cardiac Surgery
- What is being tested?
- Dressing Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 5 sitesFrance
- Study dates
- 8 Mar 2024to 25 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
C.H.U. of Angers
Angers, 49933
C.H.U. of Clermont-Ferrand
Clermont-Ferrand, 63000
C.H.U. of Limoges
Limoges, 87042
C.H.U. of Poitiers
Poitiers, 86000
C.H.U. Tours
Tours, 37044
About this study
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
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®).
Read more
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).
- Being tested
- Dressing Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dressing DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard dressing group | Active comparator | Use dry dressing, made with sterile compresses, then a glued dressing Receives: Device: Dressing Device |
| NPWT 3/7d dressing group | Experimental | Use of a PICO® dressing Receives: Device: Dressing Device |
| NPWT 7d dressing group | Experimental | Use of a PREVENA® dressing Receives: Device: Dressing Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 postoperative days
Secondary outcomes (11)
The number of dressing repairs
Measured: Between 7 and 90 postoperative days
The length of initial hospital stay
Measured: Between 7 and 90 postoperative days
The occurrence of an infection of the surgical site and its classification
Measured: At Day 90
The use of an anti-infectious treatment and its duration.
Measured: Between 7 and 90 postoperative days
The incidence of postoperative mediastinitis defined by dehiscence of the sternum with positive sternal samples.
Measured: 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.
Measured: At Day 90
The number of rehospitalizations (including consultations), and their duration.
Measured: 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?
Measured: 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? .
Measured: 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.
Measured: 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.
Measured: Between 7 and 90 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start8 Mar 2024
- Primary completion25 Aug 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complete Vertical Midline Sternotomy / Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207630
- Sponsor's protocol ID
- PRISTER
- Acronym
- PRISTER
- Status last verified
- Aug 2025
- First submitted
- 21 Dec 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41263903
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06207630
- Acronym / sponsor ID
- PRISTER / PRISTER
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard dressing group | Active comparator | Device: Dressing DeviceUse dry dressing, made with sterile compresses, then a glued dressing |
| NPWT 3/7d dressing group | Experimental | Device: Dressing DeviceUse of a PICO® dressing |
| NPWT 7d dressing group | Experimental | Device: Dressing DeviceUse of a PREVENA® dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (13 listed)
- 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:
- Patient with a history of cardiac surgery prior to inclusion
- Patient with skin infection (folliculitis) of the sternotomy site before the operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dressing DeviceUse 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. | Device | NPWT 3/7d dressing group, NPWT 7d dressing group, Standard dressing group |
Primary outcome
Complete median sternotomy wound cutaneous dehiscence
Time frame: 30 postoperative days
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.
11 secondary outcomes
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.
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.
Time frame: 7 postoperative days
The surgeon's satisfaction with the wound by means of a standardized questionnaire.
Time frame: 7 postoperative days
The incremental cost-utility ratio expressed in costs per quality-adjusted life-year (QALY) gained.
Time frame: Between 7 and 90 postoperative days
The incremental cost-effectiveness ratio expressed in costs per post-operative complication avoided
Time frame: Between 7 and 90 postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Derived from this study: PubMed 41263903Jayle 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dressing Device in people with Complete Vertical Midline Sternotomy / Cardiac Surgery, run by Poitiers University Hospital at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete median sternotomy wound cutaneous dehiscence (time frame: 30 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06207630, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.