Trial Outcomes & Findings for Pilot Trial of Chlorhexidine Gluconate (CHG) Preoperative Skin Preparation (NCT NCT02530554)
NCT ID: NCT02530554
Last Updated: 2020-09-28
Results Overview
Change was calculated as the baseline time point minus the later time points over an 8 hour period.
COMPLETED
PHASE1/PHASE2
14 participants
10 min, 6 hr and 8 hr
2020-09-28
Participant Flow
Upon achieving sufficient microbial growth prior to product application on either the abdomen and groin regions, sites of the participant were then randomized to received two products for an evaluation or up to 4 sites.
Participants were randomized to be treated with at least 2 treatments/ Arms at the same time for both groin and abdomen. Total numbers represent participants.
Unit of analysis: Sites
Participant milestones
| Measure |
CHG 3 Min Abdomen
3 min application time
|
CHG 3 Min Groin
3 min application time
|
Comparator CHG Abdomen
Comparator CHG on abdomen sites
|
Comparator CHG Groin
Comparator CHG on groin sites
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12 12
|
14 14
|
12 12
|
14 14
|
|
Overall Study
COMPLETED
|
12 12
|
14 14
|
12 12
|
14 14
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Trial of Chlorhexidine Gluconate (CHG) Preoperative Skin Preparation
Baseline characteristics by cohort
| Measure |
CHG 3 Min, Comparator CHG
n=14 Participants
CHG applied for 3 min, Comparator CHG applied per instructions.
|
|---|---|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
56 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
Romania
|
14 participants
n=99 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 10 min, 6 hr and 8 hrChange was calculated as the baseline time point minus the later time points over an 8 hour period.
Outcome measures
| Measure |
CHG 3 Min Abdomen
n=12 Sites
3 min application time
|
CHG 3 Min Groin
n=14 Sites
3 min application time
|
Comparator CHG Abdomen
n=14 Sites
CHG comparator applied to abdomen
|
Comparator CHG Groin
n=14 Sites
CHG Comparator applied to groin
|
|---|---|---|---|---|
|
Log Change in Bacterial Flora on Abdomen and Groin
10 min
|
2.9 Log (CFU)
Interval 2.1 to 3.7
|
3.7 Log (CFU)
Interval 3.0 to 4.4
|
2.3 Log (CFU)
Interval 1.5 to 3.1
|
3.0 Log (CFU)
Interval 2.3 to 3.7
|
|
Log Change in Bacterial Flora on Abdomen and Groin
6 hour
|
2.9 Log (CFU)
Interval 2.1 to 3.6
|
3.9 Log (CFU)
Interval 3.2 to 4.7
|
2.5 Log (CFU)
Interval 1.7 to 3.3
|
3.3 Log (CFU)
Interval 2.6 to 4.1
|
|
Log Change in Bacterial Flora on Abdomen and Groin
8 hour
|
2.9 Log (CFU)
Interval 2.2 to 3.6
|
4.6 Log (CFU)
Interval 3.9 to 5.3
|
2.3 Log (CFU)
Interval 1.5 to 3.0
|
3.3 Log (CFU)
Interval 2.7 to 4.0
|
Adverse Events
CHG 3 Min and Comparator CHG
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 Confidential information as part of the contract.
- Publication restrictions are in place
Restriction type: OTHER