Trial Outcomes & Findings for Preoperative CHG Cloth on Healthy Subjects (NCT NCT02291601)
NCT ID: NCT02291601
Last Updated: 2021-04-30
Results Overview
Percent of abdomen and groin sites that achieve a 2-Log or 3-Log reduction respectively of bacterial flora from baseline. Note: The number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels on the abdomen and groin at baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
879 participants
Primary outcome timeframe
10 minutes to 8 hours
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 4 sites. Differences in the number of participants is based on microbial qualification.
The sites of the participant were tested for microbial activity after product application. In some instances, more than one product could have been applied to a participant but only one product per site (groin and/or abdomen sites). Up to 4 sites could be treated : 1) both groin and abdomen, 2) only the groin or 3) only the abdomen.
Unit of analysis: sites
Participant milestones
| Measure |
CHG Cloth
CHG 3 min application
|
Vehicle
Vehicle, 3 min application
|
Comparator CHG
marketed CHG - application done per products instructions for use
|
|---|---|---|---|
|
Abdomen
STARTED
|
638 638
|
108 108
|
642 642
|
|
Abdomen
COMPLETED
|
305 305
|
54 54
|
303 303
|
|
Abdomen
NOT COMPLETED
|
333 333
|
54 54
|
339 339
|
|
Groin
STARTED
|
520 520
|
93 93
|
515 515
|
|
Groin
COMPLETED
|
337 337
|
63 63
|
338 338
|
|
Groin
NOT COMPLETED
|
183 183
|
30 30
|
177 177
|
Reasons for withdrawal
| Measure |
CHG Cloth
CHG 3 min application
|
Vehicle
Vehicle, 3 min application
|
Comparator CHG
marketed CHG - application done per products instructions for use
|
|---|---|---|---|
|
Abdomen
Did not qualify
|
333
|
54
|
339
|
|
Groin
Did not qualify
|
183
|
30
|
177
|
Baseline Characteristics
Preoperative CHG Cloth on Healthy Subjects
Baseline characteristics by cohort
| Measure |
CHG, Vehicle, Comparator CHG
n=879 Participants
Single applications of products. 3 min application for CHG and vehicle. Comparator CHG applied according to instructions.
|
|---|---|
|
Age, Categorical
<=18 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
829 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=5 Participants
|
|
Age, Continuous
|
35 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
281 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
598 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
879 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 minutes to 8 hoursPopulation: Participants received 1 or 2 products on up to 2 abdomen and 2 groin sites, 2 abdomen only sites or 2 groin sites only.
Percent of abdomen and groin sites that achieve a 2-Log or 3-Log reduction respectively of bacterial flora from baseline. Note: The number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels on the abdomen and groin at baseline.
Outcome measures
| Measure |
CHG Abdomen
n=305 sites
single application on abdomen
|
CHG Groin
n=337 sites
single application on groin.
|
Vehicle Abdomen
n=54 sites
single application on abdomen
|
Vehicle Groin
n=60 sites
single application on groin
|
Comparator Abdomen
n=303 sites
single application on abdomen
|
Comparator Groin
n=338 sites
single application of groin
|
|---|---|---|---|---|---|---|
|
Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites
8 hours
|
98 % of Treated Sites
|
100 % of Treated Sites
|
97 % of Treated Sites
|
100 % of Treated Sites
|
96 % of Treated Sites
|
100 % of Treated Sites
|
|
Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites
10 min
|
80 % of Treated Sites
|
75 % of Treated Sites
|
86 % of Treated Sites
|
65 % of Treated Sites
|
81 % of Treated Sites
|
68 % of Treated Sites
|
|
Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites
6 hours
|
99 % of Treated Sites
|
100 % of Treated Sites
|
97 % of Treated Sites
|
100 % of Treated Sites
|
96 % of Treated Sites
|
100 % of Treated Sites
|
Adverse Events
CHG Cloth
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Comparator CHG
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CHG Cloth
n=755 participants at risk
single application
|
Vehicle
n=136 participants at risk
Excipients of CHG product only.
|
Comparator CHG
n=753 participants at risk
2% CHG solution
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.2%
9/755 • Number of events 9
Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
|
0.74%
1/136 • Number of events 1
Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
|
0.40%
3/753 • Number of events 3
Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
|
|
Skin and subcutaneous tissue disorders
Irritation skin
|
0.00%
0/755
Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
|
0.74%
1/136 • Number of events 1
Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
|
0.13%
1/753 • Number of events 1
Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/755
Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
|
0.00%
0/136
Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
|
0.13%
1/753 • Number of events 1
Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
|
|
General disorders
Pain
|
0.66%
5/755 • Number of events 5
Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
|
0.00%
0/136
Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
|
0.27%
2/753 • Number of events 2
Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
|
|
Nervous system disorders
Dizziness
|
0.26%
2/755 • Number of events 2
Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
|
0.74%
1/136 • Number of events 1
Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
|
0.13%
1/753 • Number of events 1
Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/755
Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
|
0.74%
1/136 • Number of events 1
Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
|
0.00%
0/753
Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Confidential information based on contract
- Publication restrictions are in place
Restriction type: OTHER