Study of Chlorhexidine Gluconate as a Preoperative Antisepsis

Phase 3

Completed

• Conditions: Surgical Site Infection
• Interventions: Drug: Chlorhexidine gluconate; Drug: Povidone-Iodine

• Registration Number: NCT01495117
• Lead Sponsor: Seung Duk Lee

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 large bowel, stomach) is effective.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-14
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-19
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-19
• Last Update Posted: 2016-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 534

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine Gluconate	Chlorhexidine gluconate	4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting
Povidone Iodine	Povidone-Iodine	7.5% povidone iodine soaping 10% povidone iodine painting

Primary Outcome Measures

Name	Time	Method
Number of patients with Surgical Site infection within 1month	within 1 month	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

Secondary Outcome Measures

Name	Time	Method
Identify the infection source	within 1month	If SSI occur, we check the infection source including types of bacteriae using culture.
Number of patients with Drug Side effect.	Within 1 month	We check the side effect of our drugs including chlorhexidine and povidione iodine.; For example, itching sense, pruritis, ulticaria, redness, anaphylaxis
Number of patients with the postoperative sepsis induced by wound infection	within 1 month	Definition of Sepsis; 1. Proven infection (by culture, stain) or a clinical syndrome pathognomonic for infection (WBC, imaging finding or petechiae, purpura, or purpura fulminans); 2. Body temperature (\<36 or \>38 Celsus Degree); 3. Heart rate \> 90 beats per minute; 4. Respiratory rate \> 20 breaths per minute or, on blood gas, a PaCO2 less than 32 mmHg; 5. WBC count \<4000 cells/mm3 or \>12000 cells/mm3

Trial Locations

Locations (1)

National Cancer Center, Republic of Korea; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of