Trial | NCT02530528  Report issue

Title

Pilot Trial of Preoperative Chlorhexidine Gluconate (CHG) Skin Preparation
Pilot Trial Assessment of the Antimicrobial Efficacy of Medline 2% CHG Cloth Preoperative Skin Preparation

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Study Participants

    27
Pilot study to evaluate and compare activity of investigational preoperative preparation (2% CHG) with comparator (2% CHG).
Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using the Tentative Final Monograph (TFM) criteria.
Study Started
Feb 28
2014
Primary Completion
Apr 30
2014
Study Completion
Apr 30
2014
Results Posted
Apr 30
2021
Last Update
Apr 30
2021

Drug CHG

Varied application times

  • Other names: Chlorhexidine Gluconate

2% CHG 1 min Experimental

single administration, 1 min application time

2% CHG 2 min Experimental

single administration, 2 min application time

2% CHG 3 min Experimental

single administration, 3 min application time

Comparator 2% CHG Active Comparator

Single administration, Marketed CHG

Criteria 

Inclusion Criteria:

Healthy
No dermatological conditions

Exclusion Criteria:

Sensitivity to CHG
Sensitivity to natural latex rubber or adhesive skin products

Summary

CHG 1 Min

CHG 2 Min

CHG 3 Min

Comparator CHG

All Events

Event Type Organ System Event Term

Log Reduction of Bacterial Flora on Abdomen and Groin Sites

Evaluate the Log Reduction of Normal Flora at various sites and timepoints

CHG 1 Min Abdomen

10 min

2.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.65

6 hour

2.0
Log 10 Reduction (Log Mean)
Standard Deviation: 0.86

8 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.76

CHG 3 Min Groin

10 min

4.3
Log 10 Reduction (Log Mean)
Standard Deviation: 1.2

6 hour

3.5
Log 10 Reduction (Log Mean)
Standard Deviation: 0.95

8 hour

3.2
Log 10 Reduction (Log Mean)
Standard Deviation: 0.8

CHG 3 Min Groin

10 min

4.3
Log 10 Reduction (Log Mean)
Standard Deviation: 1.2

6 hour

3.5
Log 10 Reduction (Log Mean)
Standard Deviation: 0.95

8 hour

3.2
Log 10 Reduction (Log Mean)
Standard Deviation: 0.8

CHG 3 Min Groin

10 min

4.3
Log 10 Reduction (Log Mean)
Standard Deviation: 1.2

6 hour

3.5
Log 10 Reduction (Log Mean)
Standard Deviation: 0.95

8 hour

3.2
Log 10 Reduction (Log Mean)
Standard Deviation: 0.8

CHG 3 Min Groin

10 min

4.3
Log 10 Reduction (Log Mean)
Standard Deviation: 1.2

6 hour

3.5
Log 10 Reduction (Log Mean)
Standard Deviation: 0.95

8 hour

3.2
Log 10 Reduction (Log Mean)
Standard Deviation: 0.8

CHG 3 Min Groin

10 min

4.3
Log 10 Reduction (Log Mean)
Standard Deviation: 1.2

6 hour

3.5
Log 10 Reduction (Log Mean)
Standard Deviation: 0.95

8 hour

3.2
Log 10 Reduction (Log Mean)
Standard Deviation: 0.8

CHG 3 Min Groin

10 min

4.3
Log 10 Reduction (Log Mean)
Standard Deviation: 1.2

6 hour

3.5
Log 10 Reduction (Log Mean)
Standard Deviation: 0.95

8 hour

3.2
Log 10 Reduction (Log Mean)
Standard Deviation: 0.8

CHG 3 Min Groin

10 min

4.3
Log 10 Reduction (Log Mean)
Standard Deviation: 1.2

6 hour

3.5
Log 10 Reduction (Log Mean)
Standard Deviation: 0.95

8 hour

3.2
Log 10 Reduction (Log Mean)
Standard Deviation: 0.8

CHG 3 Min Groin

10 min

4.3
Log 10 Reduction (Log Mean)
Standard Deviation: 1.2

6 hour

3.5
Log 10 Reduction (Log Mean)
Standard Deviation: 0.95

8 hour

3.2
Log 10 Reduction (Log Mean)
Standard Deviation: 0.8

CHG 1 Min Abdomen

10 min

2.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.65

6 hour

2.0
Log 10 Reduction (Log Mean)
Standard Deviation: 0.86

8 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.76

Comparator CHG Abdomen

10 min

2.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.71

6 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.64

8 hour

1.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.94

Comparator CHG Abdomen

10 min

2.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.71

6 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.64

8 hour

1.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.94

Comparator CHG Abdomen

10 min

2.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.71

6 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.64

8 hour

1.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.94

Comparator CHG Abdomen

10 min

2.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.71

6 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.64

8 hour

1.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.94

Comparator CHG Abdomen

10 min

2.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.71

6 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.64

8 hour

1.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.94

Comparator CHG Abdomen

10 min

2.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.71

6 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.64

8 hour

1.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.94

Comparator CHG Abdomen

10 min

2.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.71

6 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.64

8 hour

1.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.94

Comparator CHG Abdomen

10 min

2.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.71

6 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.64

8 hour

1.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.94

Comparator CHG Groin

10 min

3.1
Log 10 Reduction (Log Mean)
Standard Deviation: 0.79

6 hour

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 1.0

8 hour

2.5
Log 10 Reduction (Log Mean)
Standard Deviation: 0.94

Comparator CHG Groin

10 min

3.1
Log 10 Reduction (Log Mean)
Standard Deviation: 0.79

6 hour

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 1.0

8 hour

2.5
Log 10 Reduction (Log Mean)
Standard Deviation: 0.94

Comparator CHG Groin

10 min

3.1
Log 10 Reduction (Log Mean)
Standard Deviation: 0.79

6 hour

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 1.0

8 hour

2.5
Log 10 Reduction (Log Mean)
Standard Deviation: 0.94

Comparator CHG Groin

10 min

3.1
Log 10 Reduction (Log Mean)
Standard Deviation: 0.79

6 hour

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 1.0

8 hour

2.5
Log 10 Reduction (Log Mean)
Standard Deviation: 0.94

Comparator CHG Groin

10 min

3.1
Log 10 Reduction (Log Mean)
Standard Deviation: 0.79

6 hour

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 1.0

8 hour

2.5
Log 10 Reduction (Log Mean)
Standard Deviation: 0.94

Comparator CHG Groin

10 min

3.1
Log 10 Reduction (Log Mean)
Standard Deviation: 0.79

6 hour

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 1.0

8 hour

2.5
Log 10 Reduction (Log Mean)
Standard Deviation: 0.94

Comparator CHG Groin

10 min

3.1
Log 10 Reduction (Log Mean)
Standard Deviation: 0.79

6 hour

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 1.0

8 hour

2.5
Log 10 Reduction (Log Mean)
Standard Deviation: 0.94

Comparator CHG Groin

10 min

3.1
Log 10 Reduction (Log Mean)
Standard Deviation: 0.79

6 hour

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 1.0

8 hour

2.5
Log 10 Reduction (Log Mean)
Standard Deviation: 0.94

CHG 1 Min Abdomen

10 min

2.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.65

6 hour

2.0
Log 10 Reduction (Log Mean)
Standard Deviation: 0.86

8 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.76

CHG 1 Min Abdomen

10 min

2.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.65

6 hour

2.0
Log 10 Reduction (Log Mean)
Standard Deviation: 0.86

8 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.76

CHG 1 Min Abdomen

10 min

2.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.65

6 hour

2.0
Log 10 Reduction (Log Mean)
Standard Deviation: 0.86

8 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.76

CHG 1 Min Abdomen

10 min

2.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.65

6 hour

2.0
Log 10 Reduction (Log Mean)
Standard Deviation: 0.86

8 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.76

CHG 1 Min Abdomen

10 min

2.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.65

6 hour

2.0
Log 10 Reduction (Log Mean)
Standard Deviation: 0.86

8 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.76

CHG 1 Min Abdomen

10 min

2.6
Log 10 Reduction (Log Mean)
Standard Deviation: 0.65

6 hour

2.0
Log 10 Reduction (Log Mean)
Standard Deviation: 0.86

8 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.76

CHG 1 Min Groin

10 min

3.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.85

6 hour

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 0.67

8 hour

2.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.38

CHG 1 Min Groin

10 min

3.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.85

6 hour

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 0.67

8 hour

2.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.38

CHG 1 Min Groin

10 min

3.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.85

6 hour

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 0.67

8 hour

2.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.38

CHG 1 Min Groin

10 min

3.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.85

6 hour

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 0.67

8 hour

2.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.38

CHG 1 Min Groin

10 min

3.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.85

6 hour

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 0.67

8 hour

2.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.38

CHG 1 Min Groin

10 min

3.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.85

6 hour

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 0.67

8 hour

2.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.38

CHG 1 Min Groin

10 min

3.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.85

6 hour

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 0.67

8 hour

2.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.38

CHG 1 Min Groin

10 min

3.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.85

6 hour

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 0.67

8 hour

2.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.38

CHG 2 Min Abdomen

10 min

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 0.60

6 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.80

8 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 1.0

CHG 2 Min Abdomen

10 min

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 0.60

6 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.80

8 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 1.0

CHG 2 Min Abdomen

10 min

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 0.60

6 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.80

8 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 1.0

CHG 2 Min Abdomen

10 min

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 0.60

6 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.80

8 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 1.0

CHG 2 Min Abdomen

10 min

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 0.60

6 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.80

8 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 1.0

CHG 2 Min Abdomen

10 min

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 0.60

6 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.80

8 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 1.0

CHG 2 Min Abdomen

10 min

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 0.60

6 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.80

8 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 1.0

CHG 2 Min Abdomen

10 min

2.7
Log 10 Reduction (Log Mean)
Standard Deviation: 0.60

6 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.80

8 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 1.0

CHG 2 Min Groin

10 min

4.2
Log 10 Reduction (Log Mean)
Standard Deviation: 1.3

6 hour

2.9
Log 10 Reduction (Log Mean)
Standard Deviation: 1.13

8 hour

3.05
Log 10 Reduction (Log Mean)
Standard Deviation: 0.83

CHG 2 Min Groin

10 min

4.2
Log 10 Reduction (Log Mean)
Standard Deviation: 1.3

6 hour

2.9
Log 10 Reduction (Log Mean)
Standard Deviation: 1.13

8 hour

3.05
Log 10 Reduction (Log Mean)
Standard Deviation: 0.83

CHG 2 Min Groin

10 min

4.2
Log 10 Reduction (Log Mean)
Standard Deviation: 1.3

6 hour

2.9
Log 10 Reduction (Log Mean)
Standard Deviation: 1.13

8 hour

3.05
Log 10 Reduction (Log Mean)
Standard Deviation: 0.83

CHG 2 Min Groin

10 min

4.2
Log 10 Reduction (Log Mean)
Standard Deviation: 1.3

6 hour

2.9
Log 10 Reduction (Log Mean)
Standard Deviation: 1.13

8 hour

3.05
Log 10 Reduction (Log Mean)
Standard Deviation: 0.83

CHG 2 Min Groin

10 min

4.2
Log 10 Reduction (Log Mean)
Standard Deviation: 1.3

6 hour

2.9
Log 10 Reduction (Log Mean)
Standard Deviation: 1.13

8 hour

3.05
Log 10 Reduction (Log Mean)
Standard Deviation: 0.83

CHG 2 Min Groin

10 min

4.2
Log 10 Reduction (Log Mean)
Standard Deviation: 1.3

6 hour

2.9
Log 10 Reduction (Log Mean)
Standard Deviation: 1.13

8 hour

3.05
Log 10 Reduction (Log Mean)
Standard Deviation: 0.83

CHG 2 Min Groin

10 min

4.2
Log 10 Reduction (Log Mean)
Standard Deviation: 1.3

6 hour

2.9
Log 10 Reduction (Log Mean)
Standard Deviation: 1.13

8 hour

3.05
Log 10 Reduction (Log Mean)
Standard Deviation: 0.83

CHG 2 Min Groin

10 min

4.2
Log 10 Reduction (Log Mean)
Standard Deviation: 1.3

6 hour

2.9
Log 10 Reduction (Log Mean)
Standard Deviation: 1.13

8 hour

3.05
Log 10 Reduction (Log Mean)
Standard Deviation: 0.83

CHG 3 Min Abdomen

10 min

2.8
Log 10 Reduction (Log Mean)
Standard Deviation: 0.46

6 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.81

8 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.67

CHG 3 Min Abdomen

10 min

2.8
Log 10 Reduction (Log Mean)
Standard Deviation: 0.46

6 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.81

8 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.67

CHG 3 Min Abdomen

10 min

2.8
Log 10 Reduction (Log Mean)
Standard Deviation: 0.46

6 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.81

8 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.67

CHG 3 Min Abdomen

10 min

2.8
Log 10 Reduction (Log Mean)
Standard Deviation: 0.46

6 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.81

8 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.67

CHG 3 Min Abdomen

10 min

2.8
Log 10 Reduction (Log Mean)
Standard Deviation: 0.46

6 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.81

8 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.67

CHG 3 Min Abdomen

10 min

2.8
Log 10 Reduction (Log Mean)
Standard Deviation: 0.46

6 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.81

8 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.67

CHG 3 Min Abdomen

10 min

2.8
Log 10 Reduction (Log Mean)
Standard Deviation: 0.46

6 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.81

8 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.67

CHG 3 Min Abdomen

10 min

2.8
Log 10 Reduction (Log Mean)
Standard Deviation: 0.46

6 hour

2.4
Log 10 Reduction (Log Mean)
Standard Deviation: 0.81

8 hour

1.9
Log 10 Reduction (Log Mean)
Standard Deviation: 0.67

Age, Continuous

36
years (Mean)
Full Range: 17.0 to 72.0

Age, Categorical

Race (NIH/OMB)

Region of Enrollment

Sex: Female, Male

Overall Study

CHG 1 Min Abdomen

CHG 1 Min Groin

CHG 2 Min Abdomen

CHG 2 Min Groin

CHG 3 Min Abdomen

CHG 3 Min Groin

Comparator CHG Abdomen

Comparator CHG Groin