Prevention of wound infections after colorectal surgery using antibiotics prior to surgery

Phase 1

• Conditions: The medical condition under investigation: surgical site infections (bacterial) after elective colorectal surgery.; MedDRA version: 19.0 Level: LLT Classification code 10053562 Term: Surgical wound infection System Organ Class: 100000004862; MedDRA version: 19.0 Level: LLT Classification code 10056641 Term: Post procedural site wound infection System Organ Class: 100000004862; MedDRA version: 19.0 Level: LLT Classification code 10074392 Term: Deep postoperative wound infection System Organ Class: 100000004862; MedDRA version: 19.0 Level: LLT Classification code 10074393 Term: Superficial postoperative wound infection System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-005736-17-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-27
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 966

Inclusion Criteria

- Adult patients (18 years of age or older) undergoing elective colorectal surgery. Elective surgery is defined as surgery for which there is no need to be performed immediately, with the possibility to be scheduled at the patient’s and surgeon’s convenience
- Abovementioned patients may not meet any of the exclusion criteria

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 483
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 483

Exclusion Criteria

Patients who meet one or more of the following criteria will not be eligible to participate in this study:

- Patients aged <18 years
- Legally incapacitated patients or patients who refuse to sign informed consent.
- Patients with an inability to take oral medication
- Patients who have undergone abdominal surgery within 30 days before randomisation
- Patients who have a known and documented allergy to any of the medications or agents used (i.e. colistin, tobramycin or other aminoglycoside antibiotics)
- Patients diagnosed with myasthenia gravis
- Pregnant women and nursing mothers
- Patients undergoing colorectal surgery in an emergency setting (i.e. not elective)
- Patients with an ileostomy
- Patients who already participated in the PreCaution trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified