Comparison of Chlorhexidine Gluconate and Povidone Iodine as a Preoperative Antisepsis in Clean-contaminated Abdominal Surgery : a Randomized Prospective Trial
20 Years
85 Years
Both
Surgical Site Infection
Trial Information
Comparison of Chlorhexidine Gluconate and Povidone Iodine as a Preoperative Antisepsis in Clean-contaminated Abdominal Surgery : a Randomized Prospective Trial
Inclusion Criteria:
1. Resection of following organs (clean-contaminated open surgery)
- Liver, Pancreas, Bile duct, Duodenum
- Stomach
- Colon, Small bowel
2. Aged 20 - 85 years old
3. Use Prophylactic antibiotics
4. Use Preoperative bowel preparation
5. Elective operation
6. 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
7. 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 Criteria:
1. allergy to chlorhexidine or povidone
2. clean surgery or contaminated surgery
3. patients who cannot be followed up during 1 month
4. patients taking immunosuppressant drugs or chemotherapy agents
5. emergent surgery and reoperation
6. uncontrolled diabetes, BMI > 30 kg/m2
7. vulnerable patients
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Number of patients with Surgical Site infection within 1month
Outcome Description:
Check the surgical site infection (SSI) rate within one month Superficial SSI, Deep SSI, Organ Site SSI decided by physician CDC Definition in 1999 Superficial incisional infection : involving only the skin or subcutaneous tissue of the incision Deep incisional Infection : involving the deep tissues (i.e. fascial and muscle layers) Organ Space Infection : involving any part of the anatomy (i.e. organ/space), other than the incision
Outcome Time Frame:
within 1 month
Safety Issue:
No
Principal Investigator
Sung-Sik Han, Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Liver Cancer Center, National Cancer Center, Republic of Korea
Authority:
Korea: Institutional Review Board
Study ID:
NCCCTS-11-563
NCT ID:
NCT01495117
Start Date:
October 2011
Completion Date:
April 2013
Related Keywords:
- Surgical Site Infection
- surgical site infection
- chlorhexidine gluconate
- povidone iodine
Name | Location |
|---|
