Trial Outcomes & Findings for Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Volunteers (NCT NCT02526667)

NCT ID: NCT02526667

Last Updated: 2020-09-28

Results Overview

Log10 reduction in bacteria on the skin evaluated at 10 minutes, 6 hours and 8 hours after treatment. Responder rates (%) are the percentage of sites identified that produced a 2-Log and 3-Log reduction from baseline for abdomen and groin sites respectively.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 340 participants
• Primary outcome timeframe: 10 minutes, 6 hours, 8 hours
• Results posted on: 2020-09-28

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 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 CHG comparator application
Abdomen STARTED	284 568	56 112	281 562
Abdomen COMPLETED	284 307	56 59	281 314
Abdomen NOT COMPLETED	0 261	0 53	0 248
Groin STARTED	290 580	56 112	294 588
Groin COMPLETED	290 291	56 55	294 294
Groin NOT COMPLETED	0 289	0 57	0 294

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Volunteers

Baseline characteristics by cohort

Measure	CHG, Vehicle, Comparator CHG n=340 Participants Single applications of products. 3 min application for CHG and Vehicle. Comparator CHG applied according to instructions.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	315 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants
Age, Continuous	38 years n=5 Participants
Sex: Female, Male Female	182 Participants n=5 Participants
Sex: Female, Male Male	158 Participants n=5 Participants
Region of Enrollment Romania	340 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 minutes, 6 hours, 8 hours

Population: Number of participants involved in the analyses.

Log10 reduction in bacteria on the skin evaluated at 10 minutes, 6 hours and 8 hours after treatment. Responder rates (%) are the percentage of sites identified that produced a 2-Log and 3-Log reduction from baseline for abdomen and groin sites respectively.

Outcome measures

Measure	CHG 3 Min Abdomen n=307 Sites single application on abdomen	CHG 3 Min Groin n=291 Sites single application on groin	Vehicle Abdomen n=59 Sites single application on abdomen	Vehicle Groin n=55 Sites single application on groin	Comparator CHG Abdomen n=314 Sites single application on abdomen	Comparator CHG Groin n=294 Sites single application on groin
Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin 6 hours	100 Percent of sites	100 Percent of sites	96 Percent of sites	100 Percent of sites	99 Percent of sites	100 Percent of sites
Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin 8 hours	99 Percent of sites	100 Percent of sites	96 Percent of sites	100 Percent of sites	98 Percent of sites	100 Percent of sites
Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin 10 min	78 Percent of sites	84 Percent of sites	54 Percent of sites	56 Percent of sites	72 Percent of sites	73 Percent of sites

Adverse Events

CHG Cloth Abdomen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle Abdomen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comparator CHG Abdomen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CHG Cloth Groin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle Groin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comparator CHG Groin

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

Dr. Olsavszky

Evic Romania

Phone: 40 21 335 70 90

Email: research@evic.ro

Results disclosure agreements

• Principal investigator is a sponsor employee Confidential information based on contract.
• Publication restrictions are in place

Restriction type: OTHER