Study of Chlorhexidine Gluconate as a Preoperative Antisepsis

Surgical Site Infection Clinical Trial

— CHG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495117
• Other study ID #: NCCCTS-11-563
• Status: Completed
• Phase: Phase 3
• First received: October 14, 2011
• Last updated: December 19, 2016
• Start date: October 2011
• Est. completion date: October 2014

Study information

• Verified date: December 2016
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Povidone-Iodine
7.5% povidone iodine soaping 10% povidone iodine painting
• Chlorhexidine gluconate
4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center, Republic of Korea	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seung Duk Lee

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	within 1 month	No
Secondary	Identify the infection source	If SSI occur, we check the infection source including types of bacteriae using culture.	within 1month	No
Secondary	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	Within 1 month	No
Secondary	Number of patients with the postoperative sepsis induced by wound infection	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	within 1 month	No