Status:
COMPLETED
Study of Chlorhexidine Gluconate as a Preoperative Antisepsis
Lead Sponsor:
Seung Duk Lee
Conditions:
Surgical Site Infection
Eligibility:
All Genders
20-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine which drug (chlorhexidine gluconate vs. povidone iodine) as a preoperative antisepsis in clean-contaminated abdominal surgery (liver, hepatobiliary, small or ...
Eligibility Criteria
Inclusion
- Resection of following organs (clean-contaminated open surgery)
- Liver, Pancreas, Bile duct, Duodenum
- Stomach
- Colon, Small bowel
- Aged 20 - 85 years old
- Use Prophylactic antibiotics
- Use Preoperative bowel preparation
- Elective operation
- ASA classification 1-2 ASA I : no known systemic disease ASA II : single systemic disease \& mild or well controlled ASA III : multiple systemic diseases or moderately controlled systemic disease ASA IV : poorly controlled systemic diseases
- adequate organ functions defined as indicated below:
- WBC 3000 \~ 12 000/mm3
- \> Hb 8.0 g/dl
- \> Plt 100 000/mm3
- \< Cr 1.2 mg/dl
Exclusion
- allergy to chlorhexidine or povidone
- clean surgery or contaminated surgery
- patients who cannot be followed up during 1 month
- patients taking immunosuppressant drugs or chemotherapy agents
- emergent surgery and reoperation
- uncontrolled diabetes, BMI \> 30 kg/m2
- vulnerable patients
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
534 Patients enrolled
Trial Details
Trial ID
NCT01495117
Start Date
October 1 2011
End Date
October 1 2014
Last Update
December 21 2016
Active Locations (1)
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1
National Cancer Center, Republic of Korea
Goyang-si, Gyeonggi-do, South Korea, 410-769