CHG: Study of Chlorhexidine Gluconate as a Preoperative Antisepsis

Sponsor

Seung Duk Lee (Other)

Overall Status

Completed

CT.gov ID

NCT01495117

Collaborator

(none)

534

Enrollment

Location

Arms

Duration (Months)

14.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection	Drug: Povidone-Iodine Drug: Chlorhexidine gluconate	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

534 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

Number of patients with Surgical Site infection within 1month [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 Outcome Measures

Identify the infection source [within 1month]
If SSI occur, we check the infection source including types of bacteriae using culture.
Number of patients with Drug Side effect. [Within 1 month]
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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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: