Study of Chlorhexidine Gluconate as a Preoperative Antisepsis (CHG)

Seung Duk Lee

Status and phase: Completed; Phase 3

Conditions: Surgical Site Infection

Treatments: Drug: Povidone-Iodine; Drug: Chlorhexidine gluconate

Study type: Interventional

Funder types: Other

Identifiers

NCT01495117

NCCCTS-11-563

Details and patient eligibility

About

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.

Enrollment: 534 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

534 participants in 2 patient groups

Povidone Iodine

Active Comparator group

Description:

7.5% povidone iodine soaping 10% povidone iodine painting

Treatment:

Drug: Povidone-Iodine

Chlorhexidine Gluconate

Active Comparator group

Description:

4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting

Treatment:

Drug: Chlorhexidine gluconate