Trial Outcomes & Findings for Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections (NCT NCT00290290)

Results Overview

The primary end point of the study was the occurrence of any surgical-site infection. Diagnosis of surgical-site infection was diagnosed by a blinded reviewer following criteria developed by the Center for Disease Control. The significance of difference between the two study groups in terms of patient characteristics was determined with the use of the Wilcoxon rank-sum test for continuous variables and Fisher's exact test for categorical variables. For efficacy outcomes, we compared the proportions of patients in the two study groups who could be evaluated and who any type of surgical-site infection using Fisher's exact test and calculating the relative risk of infection and 95% confidence intervals. To determine whether the results were consistent across the 6 participating hospitals, a prespecified Breslow-Day test for homogeneity was performed.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

849 participants

Primary outcome timeframe

during surgery and within the 30 days post surgery

Results posted on

2014-09-18

Participant Flow

Patients 18 years or older undergoing clean-contaminated surgery preformed without substantial spillage or unusual contamination were eligible for enrollment. Patients were excluded if they were allergic to chlorhexidine, alcohol, or iodophors, or had infection at or adjacent to operative site, \& if there was a perceived inability for a 30 days F/U

There were no significant events prior to group assignment. Enrolled patients were immediately and randomly assigned in a 1:1 ratio to a study arm. To help match the two groups and address potential inter-hospital differences, randomization was stratified by hospital with the use of computer-generated randomization numbers without blocking

Participant milestones

Participant milestones
Measure	Povidone-Iodine Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine	Chlorhexidine-Alcohol Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
Overall Study STARTED	440	409
Overall Study COMPLETED	422	391
Overall Study NOT COMPLETED	18	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Povidone-Iodine Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine	Chlorhexidine-Alcohol Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
Overall Study Death	3	4
Overall Study Withdrawal by Subject	2	2
Overall Study Underwent clean surgical procedure	13	12

Baseline Characteristics

Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Povidone-iodine n=440 Participants Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine	Chlorhexidine-alcohol n=409 Participants Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol	Total n=849 Participants Total of all reporting groups
Age, Continuous	52.9 years STANDARD_DEVIATION 14.2 • n=93 Participants	53.3 years STANDARD_DEVIATION 14.6 • n=4 Participants	53.1 years STANDARD_DEVIATION 14.4 • n=27 Participants
Age, Customized <18 years	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Age, Customized >18 years	440 participants n=93 Participants	409 participants n=4 Participants	849 participants n=27 Participants
Sex: Female, Male Female	194 Participants n=93 Participants	168 Participants n=4 Participants	362 Participants n=27 Participants
Sex: Female, Male Male	246 Participants n=93 Participants	241 Participants n=4 Participants	487 Participants n=27 Participants
Region of Enrollment United States	440 participants n=93 Participants	409 participants n=4 Participants	849 participants n=27 Participants

PRIMARY outcome

Timeframe: during surgery and within the 30 days post surgery

The primary end point of the study was the occurrence of any surgical-site infection. Diagnosis of surgical-site infection was diagnosed by a blinded reviewer following criteria developed by the Center for Disease Control. The significance of difference between the two study groups in terms of patient characteristics was determined with the use of the Wilcoxon rank-sum test for continuous variables and Fisher's exact test for categorical variables. For efficacy outcomes, we compared the proportions of patients in the two study groups who could be evaluated and who any type of surgical-site infection using Fisher's exact test and calculating the relative risk of infection and 95% confidence intervals. To determine whether the results were consistent across the 6 participating hospitals, a prespecified Breslow-Day test for homogeneity was performed.

Outcome measures

Outcome measures
Measure	Povidone-Iodine n=440 Participants Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine	Chlorhexidine-Alcohol n=409 Participants Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
The Primary Objective of This Trial is to Compare the Impact of Disinfecting the Skin With Chloraprep vs. Betadine on the Rates of Infection of Clean-contaminated Surgical Wounds.	16.1 Percentage of Post Operative Infections Interval 0.41 to 0.85	9.5 Percentage of Post Operative Infections Interval 0.41 to 0.85

Adverse Events

Povidone-Iodine

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Chlorhexidine-Alcohol

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Povidone-Iodine n=440 participants at risk Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine	Chlorhexidine-Alcohol n=409 participants at risk Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
Surgical and medical procedures Death	0.68% 3/440 • Number of events 3	0.98% 4/409 • Number of events 4

Other adverse events

Other adverse events
Measure	Povidone-Iodine n=440 participants at risk Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine	Chlorhexidine-Alcohol n=409 participants at risk Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
Skin and subcutaneous tissue disorders Pruritis/Erythema	0.68% 3/440 • Number of events 3	0.73% 3/409 • Number of events 3

Additional Information

Rabih Darouiche, M.D.

Baylor College of Medicine

Phone: 713-794-8858

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place