Study of Chlorhexidine Gluconate as a Preoperative Antisepsis

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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 large bowel, stomach) is effective.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seung Duk Lee
• Treatments: Cadexomer iodine; Chlorhexidine; Chlorhexidine gluconate; Iodine; Pharmaceutical Solutions; Povidone; Povidone-Iodine

Criteria

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