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Study of Chlorhexidine Gluconate as a Preoperative Antisepsis

NCT ID: NCT01495117

Last Updated: 2016-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

534 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgical Site Infection

Keywords

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surgical site infection chlorhexidine gluconate povidone iodine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Povidone Iodine

7.5% povidone iodine soaping 10% povidone iodine painting

Group Type ACTIVE_COMPARATOR

Povidone-Iodine

Intervention Type DRUG

7.5% povidone iodine soaping 10% povidone iodine painting

Chlorhexidine Gluconate

4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting

Group Type ACTIVE_COMPARATOR

Chlorhexidine gluconate

Intervention Type DRUG

4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting

Interventions

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Povidone-Iodine

7.5% povidone iodine soaping 10% povidone iodine painting

Intervention Type DRUG

Chlorhexidine gluconate

4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting

Intervention Type DRUG

Other Intervention Names

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7.5% POVICLEAN BRUSH (SUNGKWANG PHARM) 10% POVIDONE IODINE SOLUTION (SUNGKWANG PHARM) 4% HEXICLEN BRUSH (SUNGKWANG PHARM) 5% CHLORHEXIDINE GLUCONATE SOLUTION (SUNGKWANG PHARM)

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seung Duk Lee

OTHER_GOV

Sponsor Role lead

Responsible Party

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Seung Duk Lee

Clinical Fellow, Center for Liver Cancer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sung-Sik Han, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Liver Cancer Center, National Cancer Center, Republic of Korea

Locations

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National Cancer Center, Republic of Korea

Goyang-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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Park HM, Han SS, Lee EC, Lee SD, Yoon HM, Eom BW, Kim SH, Ryu KW, Park SJ, Kim YW, Park B. Randomized clinical trial of preoperative skin antisepsis with chlorhexidine gluconate or povidone-iodine. Br J Surg. 2017 Jan;104(2):e145-e150. doi: 10.1002/bjs.10395. Epub 2016 Nov 23.

Reference Type DERIVED
PMID: 27879993 (View on PubMed)

Other Identifiers

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NCCCTS-11-563

Identifier Type: -

Identifier Source: org_study_id