Study of Chlorhexidine Gluconate as a Preoperative Antisepsis (CHG)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by National Cancer Center, Korea.
Recruitment status was  Recruiting
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
  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:


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
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 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 July 22, 2014