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Completed

NCT Number: NCT02703857

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

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

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Key information

Conditions

Antibiotic Prophylaxis Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier de Poitiers

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cefoxitin

Drug

Parenteral administration of 2g of cefoxitin at least 30 minutes before incision and then every 2 hours until closing

Primary outcomes

  1. Total and free plasma of cefoxitin after repeated injections

    Time frame: 48 hours

  2. Free tissue concentration of cefoxitin every 20 minutes after the beginning of injections

    Time frame: 48 hours

  3. Concentration of cefoxitin in urine after every injection

    Time frame: 48 hours

Secondary outcomes

  1. Percentage of time when tissue concentration of cefoxitin is higher than the minimal inhibitory concentration of target organisms

    Time frame: 48 hours

  2. Concentrations of antibiotic in peritoneal fluid

    Time frame: 48 hours

  3. Clearance of distribution of cefoxitin

    Time frame: 48 hours

  4. Clearance of elimination of cefoxitin

    Time frame: 48 hours

  5. Cmax of Cefoxitin

    Time frame: 48 hours

  6. Vd of distribution o cefoxitin

    Time frame: 48 hours

  7. Area under the curve of plasma and tissue concentration of cefoxitin

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: PROPHYLOXITINE

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 9, 2016
Registry last updated
Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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