Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-02-17 @ 5:50 PM
Study NCT ID:
NCT02703857
Status:
COMPLETED
Last Update Posted:
2017-06-12
First Post:
2016-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Repeated Cefoxitin Administration in Major Abdominal Surgery Using a Microdialysis Technique
Sponsor:
Poitiers University Hospital
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2017-06
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:
PROPHYLOXITINE
Brief Summary:
The surgical site infection is one of the most important causes of postoperative morbidity. The appropriate antibiotic prophylaxis is one of the most effective ways to prevent surgical site infections. The recommendations of the French Society of Anesthesia Resuscitation on antibiotic prophylaxis in long surgeries are based on low documentation, including frequency and dosage of reinjection.
The main objective of the study is to describe the tissue and plasma pharmacokinetics of cefoxitin after repeated injections.
This is an open monocentric study (phase 4) including adults aged 18 to 80 years in need of major abdominal surgery whose foreseeable time exceeds 4 hours and justifying an antibiotic prophylaxis by cefoxitin.
They receive 2 g cefoxitin parenterally at least 30 minutes before the incision and then every 2 hours until closing.
The primary endpoints are:
* Total and plasma free concentrations of cefoxitin 0, 10, 30, 60, 90, 120 minutes after start of each infusion cefoxitin
* Tissue free concentrations of cefoxitin every 20 minutes after the start of the first infusion cefoxitin until skin closure
* Urinary concentrations of cefoxitin
The main objective of the study is to describe the tissue and plasma pharmacokinetics of cefoxitin after repeated injections.
This is an open monocentric study (phase 4) including adults aged 18 to 80 years in need of major abdominal surgery whose foreseeable time exceeds 4 hours and justifying an antibiotic prophylaxis by cefoxitin.
They receive 2 g cefoxitin parenterally at least 30 minutes before the incision and then every 2 hours until closing.
The primary endpoints are:
* Total and plasma free concentrations of cefoxitin 0, 10, 30, 60, 90, 120 minutes after start of each infusion cefoxitin
* Tissue free concentrations of cefoxitin every 20 minutes after the start of the first infusion cefoxitin until skin closure
* Urinary concentrations of cefoxitin
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: