NL-OMON47368
Completed
Phase 3
Prevention of severe infectious complications after colorectal surgery using antimicrobial decontamination of the digestive tract - PreCaution
niversitair Medisch Centrum Utrecht0 sites966 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Surgical site infection
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 966
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult patients (18 years of age or older)
- •2\. Patients undergoing elective colorectal surgery.;Abovementioned patients may not meet any of the exclusion criteria
Exclusion Criteria
- •Patients who meet one or more of the following criteria will not be eligible to participate in this study:;1\. Patients younger than 18 years of age
- •2\. Legally incapacitated patients or patients who refuse to sign informed consent.
- •3\. Patients with an inability to take oral medication
- •4\. Patients who have undergone abdominal surgery within 30 days before randomisation
- •5\. Patients who have a known and documented allergy to any of the medications or agents used (i.e. colistin, tobramycin or other aminoglycoside antibiotics)
- •6\. Patients diagnosed with myasthenia gravis
- •7\. Pregnant women and nursing mothers
- •8\. Patients undergoing colorectal surgery in an emergency setting (i.e. not elective)
- •9\. Patients with a stoma
- •10\. Patients who already participated in the PreCaution trial
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Prevention of wound infections after colorectal surgery using antibiotics prior to surgeryEUCTR2015-005736-17-NLniversity Medical Center Utrecht966
Suspended
Not Applicable
Prevention of wound infections after colorectal surgery using antibiotics prior to surgerySurgical site infectionPost procedural wound infectionPostoperative wound infectionColorectal surgeryDutch: Postoperatieve wondinfectieColorectale operatieNL-OMON20443niversity Medical Center Utrecht966
Completed
Not Applicable
Interventions to reduce complications of tracheal intubation.Health Condition 1: R068- Other abnormalities of breathingCTRI/2021/11/038089Dr Supradip Ghosh56
Active, not recruiting
Phase 1
PREvention of Complications to Improve Outcome in elderly patients with acute Stroke.EUCTR2015-003179-32-GRniversity Medical Center Utrecht3,800
Active, not recruiting
Phase 1
PREvention of Complications to Improve Outcome in elderly patients with acute Stroke.Stroke (ischaemic stroke or intracerebral hemorrhage)MedDRA version: 20.0Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: LLTClassification code 10022754Term: Intracerebral hemorrhageSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: LLTClassification code 10042244Term: StrokeSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2015-003179-32-HUniversity Medical Center Utrecht3,800