Trial Outcomes & Findings for Pre-operative Preparation Using 2% Chlorhexidine Cloth For Shoulder Surgery (NCT NCT01090479)

NCT ID: NCT01090479

Last Updated: 2023-05-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: 2 months post-operatively
• Results posted on: 2023-05-23

Participant Flow

Participant milestones

Measure	Control This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.	2% Chlorhexidine Cloth This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pre-operative Preparation Using 2% Chlorhexidine Cloth For Shoulder Surgery

Baseline characteristics by cohort

Measure	Control n=50 Participants This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.	2% Chlorhexidine Cloth n=50 Participants This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants	43 Participants n=7 Participants	89 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Age, Continuous	52.0 years STANDARD_DEVIATION 8 • n=5 Participants	49.0 years STANDARD_DEVIATION 9 • n=7 Participants	50.5 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	36 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	14 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months post-operatively

Outcome measures

Measure	Control n=50 Participants	Chlorhexidine n=50 Participants
Number of Patients With a Clinically Diagnosed Infection	0 participants	0 participants

SECONDARY outcome

Timeframe: 7 days

Population: Rate of positive cultures from entire shoulder region (combined from axilla and posterior shoulder)

Rate of positive cultures from entire shoulder region (combined from axilla and posterior shoulder)

Outcome measures

Measure	Control n=50 Participants	Chlorhexidine n=50 Participants
Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery	94 percentage of participants	66 percentage of participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2% Chlorhexidine Cloth

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

Michael Murray, MD

Northwestern University

Phone: 312-926-4444

Email: m.murray8278@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place