Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207630
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2023-12-21
Brief Title:
Prevention of the Risk of Complete Sternotomy Scar Dehiscence in Cardiac Surgery A Clinical Investigation Comparing Negative Pressure Wound Therapy NPWT vs Standard Dressing
Sponsor:
Poitiers University Hospital
Organization:
Poitiers University Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRISTER
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None