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Study of Chlorhexidine Gluconate as a Preoperative Antisepsis (CHG)

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ClinicalTrials.gov Identifier: NCT01495117
Recruitment Status : Completed
First Posted : December 19, 2011
Last Update Posted : December 21, 2016
Information provided by (Responsible Party):
Seung Duk Lee, National Cancer Center, Korea

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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: Povidone-Iodine Drug: Chlorhexidine gluconate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 534 participants
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
Study Start Date : October 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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:

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:

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

  2. 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

  3. 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

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495117

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Korea, Republic of
National Cancer Center, Republic of Korea
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Sponsors and Collaborators
Seung Duk Lee
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Principal Investigator: Sung-Sik Han, Ph.D. Liver Cancer Center, National Cancer Center, Republic of Korea
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seung Duk Lee, Clinical Fellow, Center for Liver Cancer, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01495117    
Other Study ID Numbers: NCCCTS-11-563
First Posted: December 19, 2011    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016
Keywords provided by Seung Duk Lee, National Cancer Center, Korea:
surgical site infection
chlorhexidine gluconate
povidone iodine
Additional relevant MeSH terms:
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Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Chlorhexidine gluconate
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents
Trace Elements
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes