NCT01495117

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
534

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 19, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 21, 2016

Status Verified

December 1, 2016

Enrollment Period

3 years

First QC Date

October 14, 2011

Last Update Submit

December 19, 2016

Conditions

Surgical Site Infection

Keywords

surgical site infectionchlorhexidine gluconatepovidone iodine

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Identify the infection source

    within 1month

  • Number of patients with Drug Side effect.

    Within 1 month

  • Number of patients with the postoperative sepsis induced by wound infection

    within 1 month

Study Arms (2)

Povidone Iodine

ACTIVE COMPARATOR

7.5% povidone iodine soaping 10% povidone iodine painting

Drug: Povidone-Iodine

Chlorhexidine Gluconate

ACTIVE COMPARATOR

4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting

Drug: Chlorhexidine gluconate

Interventions

Povidone-IodineDRUG

7.5% povidone iodine soaping 10% povidone iodine painting

Also known as: 7.5% POVICLEAN BRUSH (SUNGKWANG PHARM), 10% POVIDONE IODINE SOLUTION (SUNGKWANG PHARM)
Povidone Iodine
Chlorhexidine gluconateDRUG

4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting

Also known as: 4% HEXICLEN BRUSH (SUNGKWANG PHARM), 5% CHLORHEXIDINE GLUCONATE SOLUTION (SUNGKWANG PHARM)
Chlorhexidine Gluconate

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center, Republic of Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 27879993DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Povidone-Iodinechlorhexidine gluconate

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Sung-Sik Han, Ph.D.

    Liver Cancer Center, National Cancer Center, Republic of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Fellow, Center for Liver Cancer

Study Record Dates

First Submitted

October 14, 2011

First Posted

December 19, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

December 21, 2016

Record last verified: 2016-12

Locations

KR(1)