Study of Chlorhexidine Gluconate as a Preoperative Antisepsis (CHG)

Comparison of Chlorhexidine Gluconate and Povidone Iodine as a Preoperative Antisepsis in Clean-contaminated Abdominal Surgery : a Randomized Prospective Trial

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.

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection
• Intervention / Treatment: Drug: Povidone-Iodine; Drug: Chlorhexidine gluconate

• Study Type: Interventional
• Enrollment (Actual): 534
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
      • National Cancer Center, Republic of Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Povidone Iodine; 7.5% povidone iodine soaping 10% povidone iodine painting	Drug: Povidone-Iodine; 7.5% povidone iodine soaping 10% povidone iodine painting; Other Names: 7.5% POVICLEAN BRUSH (SUNGKWANG PHARM); 10% POVIDONE IODINE SOLUTION (SUNGKWANG PHARM)
Active Comparator: Chlorhexidine Gluconate; 4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting	Drug: Chlorhexidine gluconate; 4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting; Other Names: 4% HEXICLEN BRUSH (SUNGKWANG PHARM); 5% CHLORHEXIDINE GLUCONATE SOLUTION (SUNGKWANG PHARM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with Surgical Site infection within 1month	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	within 1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seung Duk Lee
• Investigators: Principal Investigator: Sung-Sik Han, Ph.D., Liver Cancer Center, National Cancer Center, Republic of Korea

Publications and helpful links

General Publications

• Park HM, Han SS, Lee EC, Lee SD, Yoon HM, Eom BW, Kim SH, Ryu KW, Park SJ, Kim YW, Park B. Randomized clinical trial of preoperative skin antisepsis with chlorhexidine gluconate or povidone-iodine. Br J Surg. 2017 Jan;104(2):e145-e150. doi: 10.1002/bjs.10395. Epub 2016 Nov 23.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 14, 2011
• First Submitted That Met QC Criteria: December 15, 2011
• First Posted (Estimate): December 19, 2011

Study Record Updates

• Last Update Posted (Estimate): December 21, 2016
• Last Update Submitted That Met QC Criteria: December 19, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: surgical site infection; chlorhexidine gluconate; povidone iodine
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Surgical Wound Infection; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Trace Elements; Micronutrients; Disinfectants; Plasma Substitutes; Blood Substitutes; Iodine; Pharmaceutical Solutions; Chlorhexidine; Povidone-Iodine; Povidone; Chlorhexidine gluconate
• Other Study ID Numbers: NCCCTS-11-563