N/A
N=80
Skin Prep to Reduce Postoperative Shoulder Infection
Shoulder Infection
Bottom Line
View on ClinicalTrials.gov: NCT02510144 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Skin Swab and Culture With Colony Forming Units (CFUs) — 39; 51; 35; 22 negative skin cultures — p=0.68
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Skin Prep Chlorhexidine (Drug); Skin Prep Benzoyl Peroxide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Skin Swab and Culture With Colony Forming Units (CFUs) |
39; 51; 35; 22 | 0.68 |
| SECONDARY Surgical Site Infection That Requires Antibiotics |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age >18
- Indicated for shoulder surgery
Exclusion Criteria
- History of previous shoulder infection
- Allergy to Chlorhexidine or benzoyl peroxide
- Current use of anti-acne medicine around the shoulder
- Patient is pregnant or concerned about pregnancy
Data sourced from ClinicalTrials.gov (NCT02510144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.