Trials / Completed
CompletedNCT03115177
Can Addition of Doxycycline Perioperatively Reduce Propionibacterium Acnes in Shoulder Arthroplasty?
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Rush University Medical Center · Academic / Other
- Sex
- All
- Age
- 40 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to investigate antibiotic treatment to target bacteria about the shoulder. This bacteria, Propionibacterium acnes, is detected in many revision shoulder surgeries and is thought to contribute to periprosthetic joint infections, pain, and failure of total shoulder arthroplasty as well as other shoulder surgeries. This study is investigating adding an FDA approved antibiotic that is commonly used for treatment of this bacteria and many common infections. The investigators will take intraoperative cultures to look for the presence or absence of specific bacteria. The investigators are conducting this trial to see if adding another antibiotic to specifically target this common bacteria found around the shoulder will be effective.
Detailed description
Patients undergoing total and reverse shoulder arthroplasty for primary glenohumeral arthritis will be invited to participate in this study if patients meet inclusion and exclusion criteria. Patients will be randomized to receive either standard perioperative antibiotics with cefazolin or to the treatment group to receive doxycycline in addition to cefazolin. Patients will then undergo routine surgical treatment. 3 cultures from the superficial tissue, dermis, and glenohumeral joint will be taken and cultured for 14 days to detect any bacterial growth.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Doxycycline | The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision for total shoulder arthroplasty. |
| DRUG | Cefazolin |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2017-02-01
- Completion
- 2017-02-01
- First posted
- 2017-04-14
- Last updated
- 2018-06-15
- Results posted
- 2018-06-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03115177. Inclusion in this directory is not an endorsement.