This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Study of Chlorhexidine Gluconate as a Preoperative Antisepsis (CHG)

This study has been completed.
Information provided by (Responsible Party):
Seung Duk Lee, National Cancer Center, Korea Identifier:
First received: October 14, 2011
Last updated: December 19, 2016
Last verified: December 2016
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.

Condition Intervention Phase
Surgical Site Infection Drug: Povidone-Iodine Drug: Chlorhexidine gluconate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Chlorhexidine Gluconate and Povidone Iodine as a Preoperative Antisepsis in Clean-contaminated Abdominal Surgery : a Randomized Prospective Trial

Resource links provided by NLM:

Further study details as provided by Seung Duk Lee, National Cancer Center, Korea:

Primary Outcome Measures:
  • Number of patients with Surgical Site infection within 1month [ Time Frame: 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:
  • Identify the infection source [ Time Frame: within 1month ]
    If SSI occur, we check the infection source including types of bacteriae using culture.

  • Number of patients with Drug Side effect. [ Time Frame: 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 [ Time Frame: 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

Enrollment: 534
Study Start Date: October 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
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:


Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01495117

Korea, Republic of
National Cancer Center, Republic of Korea
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Sponsors and Collaborators
Seung Duk Lee
Principal Investigator: Sung-Sik Han, Ph.D. Liver Cancer Center, National Cancer Center, Republic of Korea
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Seung Duk Lee, Clinical Fellow, Center for Liver Cancer, National Cancer Center, Korea Identifier: NCT01495117     History of Changes
Other Study ID Numbers: NCCCTS-11-563
Study First Received: October 14, 2011
Last Updated: December 19, 2016

Keywords provided by Seung Duk Lee, National Cancer Center, Korea:
surgical site infection
chlorhexidine gluconate
povidone iodine

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Pharmaceutical Solutions
Chlorhexidine gluconate
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents
Trace Elements
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes processed this record on September 19, 2017