Study of Repeated Cefoxitin Administration in Major Abdominal Surgery Using a Microdialysis Technique (PROPHYLOXITINE)

June 9, 2017 updated by: Poitiers University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France, 86021
        • Centre Hospitalier de Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who underwent major abdominal surgery whose forseeable time exceeds 4 hours and requires an antibiotic prophylaxis by cefoxitin

Exclusion Criteria:

  • morbid obesity (BMI > 35 kg/m²)
  • severe renal impairment (clearance creatinine < 30ml/min)
  • beta lactam hypersensitivity
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total and free plasma of cefoxitin after repeated injections
Time Frame: 48 hours
48 hours
Free tissue concentration of cefoxitin every 20 minutes after the beginning of injections
Time Frame: 48 hours
48 hours
Concentration of cefoxitin in urine after every injection
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of time when tissue concentration of cefoxitin is higher than the minimal inhibitory concentration of target organisms
Time Frame: 48 hours
48 hours
Concentrations of antibiotic in peritoneal fluid
Time Frame: 48 hours
48 hours
Clearance of distribution of cefoxitin
Time Frame: 48 hours
48 hours
Clearance of elimination of cefoxitin
Time Frame: 48 hours
48 hours
Cmax of Cefoxitin
Time Frame: 48 hours
48 hours
Vd of distribution o cefoxitin
Time Frame: 48 hours
48 hours
Area under the curve of plasma and tissue concentration of cefoxitin
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

September 15, 2016

Study Completion

September 20, 2016

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

March 8, 2016

First Posted (Estimate)

March 9, 2016

Study Record Updates

Last Update Posted (Actual)

June 12, 2017

Last Update Submitted That Met QC Criteria

June 9, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROPHYLOXITINE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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