Triclosan-coated sutures reduce the incidence of surgical site infections and intrabdominal infection: a double-blind randomized controlled trial.
Not Applicable
Recruiting
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0006009
- Lead Sponsor
- Gachon University Gil Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 3348
Inclusion Criteria
1.age = 20
2.predocumented abdominal-CT or MRI or PET-CT
3.No prior history of surgery
4. ECOG performance status of 0~2
5.adequate hepatic, renal and cardiac functions
6.provision of a signed written informed consent
7.elective GI surgery
Exclusion Criteria
1.patient who refuses absorbable sutures
2.medical condition in which surgery cannot be tolerated
3. patient with contaminated wound
4. Famale patients who are pregnant or lactating, Women of childbearing age are not a contraceptive
5. Any other clinically significant medical disease or psychiatric condition that in the
Investigator’s opinion
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SSI rate according to Center for Disease Control’s (CDC) definition within 30 days after surgery
- Secondary Outcome Measures
Name Time Method collection of Adverse Event & safety