Study of Chlorhexidine Gluconate as a Preoperative Antisepsis

Seung Duk Lee534 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

534

Conditions

Surgical Site Infection

Interventions

Povidone-IodineDRUG

7.5% povidone iodine soaping 10% povidone iodine painting

Chlorhexidine gluconateDRUG

4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

National Cancer Center, Republic of Korea

Goyang-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Number of patients with Surgical Site infection within 1month

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

Time frame: within 1 month

Secondary Outcomes

Identify the infection source

If SSI occur, we check the infection source including types of bacteriae using culture.

Time frame: within 1month

Number of patients with Drug Side effect.

We check the side effect of our drugs including chlorhexidine and povidione iodine. For example, itching sense, pruritis, ulticaria, redness, anaphylaxis

Time frame: Within 1 month

Number of patients with the postoperative sepsis induced by wound infection

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

Time frame: within 1 month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.