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Study of Chlorhexidine Gluconate as a Preoperative Antisepsis (CHG)

This study is currently recruiting participants.
Verified December 2011 by National Cancer Center, Korea
Sponsor:
Information provided by (Responsible Party):
Seung Duk Lee, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01495117
First received: October 14, 2011
Last updated: December 15, 2011
Last verified: December 2011
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Number of patients with Surgical Site infection within 1month [ Time Frame: within 1 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 584
Study Start Date: October 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: February 2013 (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:
  • 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)

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495117

Contacts
Contact: Seung Duk Lee, M.D. 82-31-920-1779 lsd@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center, Republic of Korea Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Seung Duk Lee, M.D.     82-31-920-1779     lsd@ncc.re.kr    
Principal Investigator: Sung-Sik Han, Ph.D.            
Sponsors and Collaborators
Seung Duk Lee
Investigators
Principal Investigator: Sung-Sik Han, Ph.D. Liver Cancer Center, National Cancer Center, Republic of Korea
  More Information

No publications provided

Responsible Party: Seung Duk Lee, Clinical Fellow, Center for Liver Cancer, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01495117     History of Changes
Other Study ID Numbers: NCCCTS-11-563
Study First Received: October 14, 2011
Last Updated: December 15, 2011
Health Authority: Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Povidone
Chlorhexidine
Chlorhexidine gluconate
Iodine
Cadexomer iodine
Povidone-Iodine
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 13, 2013