drugset
drugset / Trial / NCT02510144

Skin Prep to Reduce Postoperative Shoulder Infection

NCT02510144 ↗

Completed 80 enrolled University of Maryland, Baltimore
RandomizedParallel-groupTriple-blindPrevention

Summary

Propionibacterium acnes is the most common pathogen identified from a surgical site infection in the shoulder. Standard skin preps do not prevent this type of infection. Patients will undergo either a chlorhexidine or benzoyl peroxide prep in days leading up to surgery. Bacterial burden will be determined at the time of surgery.

Timeline

Start
2015-08
Primary completion
2018-07
Completion
2018-07

Outcome

Mixed primary results

registry analysis (superiority test); Chlorhexidine; p = 0.68; t-test, 2 sided NCT02510144 ↗

registry analysis (superiority test); Benzoyl Peroxide; p <0.01; t-test, 2 sided NCT02510144 ↗

registry NUMBER Benzoyl Peroxide: Intervention: 51 negative skin cultures NCT02510144 ↗

registry NUMBER Benzoyl Peroxide: Control: 22 negative skin cultures NCT02510144 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Benzoyl Peroxide Other / unclassified 5 % Topical
Comparator Chlorhexidine Small molecule 4 % Topical

Indications

No indication recorded.