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Completed

NCT Number: NCT01495117

Study of Chlorhexidine Gluconate as a Preoperative Antisepsis

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.

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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Cancer Center, Republic of Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Resection of following organs (clean-contaminated open surgery)
  • Liver, Pancreas, Bile duct, Duodenum
  • Stomach
  • Colon, Small bowel
  • Aged 20 - 85 years old
  • Use Prophylactic antibiotics
  • Use Preoperative bowel preparation
  • Elective operation
  • 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
  • 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

  • allergy to chlorhexidine or povidone
  • clean surgery or contaminated surgery
  • patients who cannot be followed up during 1 month
  • patients taking immunosuppressant drugs or chemotherapy agents
  • emergent surgery and reoperation
  • uncontrolled diabetes, BMI > 30 kg/m2
  • vulnerable patients

Treatment and study plan

Povidone-Iodine

Drug

7.5% povidone iodine soaping 10% povidone iodine painting

Other names: 7.5% POVICLEAN BRUSH (SUNGKWANG PHARM), 10% POVIDONE IODINE SOLUTION (SUNGKWANG PHARM)

Chlorhexidine gluconate

Drug

4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting

Other names: 4% HEXICLEN BRUSH (SUNGKWANG PHARM), 5% CHLORHEXIDINE GLUCONATE SOLUTION (SUNGKWANG PHARM)

Primary outcomes

  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 outcomes

  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

    • 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

Sponsors and collaborators

Lead sponsor

Seung Duk Lee

Other Gov

Registry information

Official study title

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

Acronym: CHG

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 19, 2011
Registry last updated
Dec 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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