search
Back to results

Study of Chlorhexidine Gluconate as a Preoperative Antisepsis (CHG)

Primary Purpose

Surgical Site Infection

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Povidone-Iodine
Chlorhexidine gluconate
Sponsored by
Seung Duk Lee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring surgical site infection, chlorhexidine gluconate, povidone iodine

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer Center, Republic of Korea

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Povidone Iodine

Chlorhexidine Gluconate

Arm Description

7.5% povidone iodine soaping 10% povidone iodine painting

4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 14, 2011
Last Updated
December 19, 2016
Sponsor
Seung Duk Lee
search

1. Study Identification

Unique Protocol Identification Number
NCT01495117
Brief Title
Study of Chlorhexidine Gluconate as a Preoperative Antisepsis
Acronym
CHG
Official Title
Comparison of Chlorhexidine Gluconate and Povidone Iodine as a Preoperative Antisepsis in Clean-contaminated Abdominal Surgery : a Randomized Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung Duk Lee

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
surgical site infection, chlorhexidine gluconate, povidone iodine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
534 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Povidone Iodine
Arm Type
Active Comparator
Arm Description
7.5% povidone iodine soaping 10% povidone iodine painting
Arm Title
Chlorhexidine Gluconate
Arm Type
Active Comparator
Arm Description
4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting
Intervention Type
Drug
Intervention Name(s)
Povidone-Iodine
Other Intervention Name(s)
7.5% POVICLEAN BRUSH (SUNGKWANG PHARM), 10% POVIDONE IODINE SOLUTION (SUNGKWANG PHARM)
Intervention Description
7.5% povidone iodine soaping 10% povidone iodine painting
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate
Other Intervention Name(s)
4% HEXICLEN BRUSH (SUNGKWANG PHARM), 5% CHLORHEXIDINE GLUCONATE SOLUTION (SUNGKWANG PHARM)
Intervention Description
4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting
Primary Outcome Measure Information:
Title
Number of patients with Surgical Site infection within 1month
Description
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 Outcome Measure Information:
Title
Identify the infection source
Description
If SSI occur, we check the infection source including types of bacteriae using culture.
Time Frame
within 1month
Title
Number of patients with Drug Side effect.
Description
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
Title
Number of patients with the postoperative sepsis induced by wound infection
Description
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
Time Frame
within 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Sik Han, Ph.D.
Organizational Affiliation
Liver Cancer Center, National Cancer Center, Republic of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center, Republic of Korea
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27879993
Citation
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.
Results Reference
derived

Learn more about this trial

Study of Chlorhexidine Gluconate as a Preoperative Antisepsis

We'll reach out to this number within 24 hrs