Trial Outcomes & Findings for Pilot Trial of Preoperative Chlorhexidine Gluconate (CHG) Skin Preparation (NCT NCT02530528)
NCT ID: NCT02530528
Last Updated: 2021-04-30
Results Overview
Evaluate the Log Reduction of Normal Flora at various sites and timepoints
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
10 min, 6 hr and 8 hr
Results posted on
2021-04-30
Participant Flow
Upon achieving sufficient microbial growth prior to product application on either the abdomen, groin or both abdomen and groin regions, sites of the participant were then randomized to receive one or two products for evaluation for up to 4 sites. Differences in the number of participants is based on microbial qualifications.
Participants were randomized to be treated with at least 2 treatments/Arms (out of 4) at the same time for both groin and abdomen. Numbers represent the total sites tested.
Unit of analysis: sites
Participant milestones
| Measure |
CHG 1 Min Abdomen
1 min application time
CHG: Varied application times
|
CHG 1 Min Groin
1 min application time
CHG: Varied application times
|
CHG 2 Min Abdomen
2 min application time
CHG: Varied application times
|
CHG 2 Min Groin
2 min application time
CHG: Varied application times
|
CHG 3 Min Abdomen
3 min application time
|
CHG 3 Min Groin
3 min application time
|
Comparator CHG Abdomen
Marketed CHG - only applied per products instructions for use
|
Comparator CHG Groin
Marketed CHG - only applied per products instructions for use
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13 13
|
13 13
|
14 14
|
14 14
|
13 13
|
13 13
|
14 14
|
14 14
|
|
Overall Study
COMPLETED
|
12 12
|
12 12
|
12 12
|
12 12
|
12 12
|
12 12
|
12 12
|
12 12
|
|
Overall Study
NOT COMPLETED
|
1 1
|
1 1
|
2 2
|
2 2
|
1 1
|
1 1
|
2 2
|
2 2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Trial of Preoperative Chlorhexidine Gluconate (CHG) Skin Preparation
Baseline characteristics by cohort
| Measure |
CHG 1, CHG 2, CHG 3, Comparator CHG
n=34 Participants
Participants could receive up to 2 different treatments at the same time. Treatments included CHG at 1 min, CHG at 2 min, CHG at 3 min or Comparator CHG.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
36 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 10 min, 6 hr and 8 hrPopulation: The data represents the number of sites (abdomen/groin) tested.
Evaluate the Log Reduction of Normal Flora at various sites and timepoints
Outcome measures
| Measure |
CHG 1 Min Abdomen
n=12 Sites
1 min application time.
|
CHG 1 Min Groin
n=12 Sites
1 min application time.
|
CHG 2 Min Abdomen
n=12 Sites
2 min application time.
|
CHG 2 Min Groin
n=12 Sites
2 min application time
|
CHG 3 Min Abdomen
n=12 Sites
3 minute application time
|
CHG 3 Min Groin
n=12 Sites
3 minute application time
|
Comparator CHG Abdomen
n=12 Sites
Comparator CHG solution
|
Comparator CHG Groin
n=12 Sites
Comparator CHG solution
|
|---|---|---|---|---|---|---|---|---|
|
Log Reduction of Bacterial Flora on Abdomen and Groin Sites
10 min
|
2.6 Log 10 Reduction
Standard Deviation 0.65
|
3.4 Log 10 Reduction
Standard Deviation 0.85
|
2.7 Log 10 Reduction
Standard Deviation 0.60
|
4.2 Log 10 Reduction
Standard Deviation 1.3
|
2.8 Log 10 Reduction
Standard Deviation 0.46
|
4.3 Log 10 Reduction
Standard Deviation 1.2
|
2.6 Log 10 Reduction
Standard Deviation 0.71
|
3.1 Log 10 Reduction
Standard Deviation 0.79
|
|
Log Reduction of Bacterial Flora on Abdomen and Groin Sites
6 hour
|
2.0 Log 10 Reduction
Standard Deviation 0.86
|
2.7 Log 10 Reduction
Standard Deviation 0.67
|
2.4 Log 10 Reduction
Standard Deviation 0.80
|
2.9 Log 10 Reduction
Standard Deviation 1.13
|
2.4 Log 10 Reduction
Standard Deviation 0.81
|
3.5 Log 10 Reduction
Standard Deviation 0.95
|
1.9 Log 10 Reduction
Standard Deviation 0.64
|
2.7 Log 10 Reduction
Standard Deviation 1.0
|
|
Log Reduction of Bacterial Flora on Abdomen and Groin Sites
8 hour
|
1.9 Log 10 Reduction
Standard Deviation 0.76
|
2.9 Log 10 Reduction
Standard Deviation 0.38
|
2.4 Log 10 Reduction
Standard Deviation 1.0
|
3.05 Log 10 Reduction
Standard Deviation 0.83
|
1.9 Log 10 Reduction
Standard Deviation 0.67
|
3.2 Log 10 Reduction
Standard Deviation 0.8
|
1.6 Log 10 Reduction
Standard Deviation 0.94
|
2.5 Log 10 Reduction
Standard Deviation 0.94
|
Adverse Events
CHG 1 Min
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CHG 2 Min
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CHG 3 Min
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Comparator CHG
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Data remains confidential
- Publication restrictions are in place
Restriction type: OTHER