Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506032
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-28
Brief Title:
Vancomycin and Negative Pressure Therapy for Post-sternotomy Deep Sternal Wound Infection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Effect and Wound Penetration of Vancomycin in Open-heart Surgery Patients Receiving Negative Pressure Wound Therapy for Deep Sternal Wound Infection
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Only a limited number of studies have been published that monitored the penetration of antibiotics from blood into exudate in patients treated with negative pressure wound therapy NPWT and that evaluated the adequacy of current dosage regimens according to antibiotic tissue concentrations A higher migration rate of several antibiotics including vancomycin to exudate has been reported in patients with skin ulcers skin defects burns and traumatic wounds treated with NPWT compared to patients without NPWT
In the present study the investigators will evaluate the pharmacokinetic profile and wound penetration of vancomycin in open-heart surgery patients with post-sternotomy deep sternal wound infection receiving NPWT
In the present study the investigators will evaluate the pharmacokinetic profile and wound penetration of vancomycin in open-heart surgery patients with post-sternotomy deep sternal wound infection receiving NPWT
Detailed Description:
For this prospective observational study consecutive patients treated with NPWT for post-sternotomy deep sternal wound infection DSWI will be enrolled On the first day of the study serum and exudate samples will be synchronously collected at 0 pre-dose 05 1 2 3 and 6 hours after vancomycin administration On the following three consecutive days additional samples will be collected only before vancomycin administration
The ratio of average vancomycin concentration in wound exudate to serum will be observed for free unbound and for total bound unbound concentration The percentage of free vancomycin in wound exudate and in serum will be observed The level of vancomycin wound penetration will be observed for three days The total hospital stay in patients with DSWI versus those without DSWI will be recorded together with the in-hospital or 90-day mortality together with late DSWI recurrence All-cause mortality will be analyzed during a median follow-up of 25 years
The ratio of average vancomycin concentration in wound exudate to serum will be observed for free unbound and for total bound unbound concentration The percentage of free vancomycin in wound exudate and in serum will be observed The level of vancomycin wound penetration will be observed for three days The total hospital stay in patients with DSWI versus those without DSWI will be recorded together with the in-hospital or 90-day mortality together with late DSWI recurrence All-cause mortality will be analyzed during a median follow-up of 25 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None