Can Addition of Doxycycline Perioperatively Reduce Propionibacterium Acnes in Shoulder Arthroplasty?
- Registration Number
- NCT03115177
- Lead Sponsor
- Rush University Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- Patients undergoing primary total shoulder arthroplasty at Rush University Medical Center
- Patients with prior shoulder surgery of any kind
- Patients with a known infection or history of infection with clinical signs such as elevated erythrocyte sedimentation rate, C-reactive protein, positive culture aspiration
- Patients with a known allergy to doxycycline
- Patients with a known allergy to cefazolin or penicillin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cefazolin Cefazolin All patients will receive standard perioperative antibiotics with 2g of cefazolin within 1 hour of incision. The control group will not receive any further antibiotic treatment. Doxycycline+Cefazolin Group Doxycycline All patients will receive standard perioperative antibiotics with 2g of cefazolin within 1 hour of incision. The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision. Doxycycline+Cefazolin Group Cefazolin All patients will receive standard perioperative antibiotics with 2g of cefazolin within 1 hour of incision. The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision.
- Primary Outcome Measures
Name Time Method Bacterial Culture 2 weeks Intraoperative cultures will be taken from all study participants and tested for detection of bacteria. These cultures were held for 14 days and tested for aerobic and anaerobic bacteria. Reported data are presented for the number of participants with a positive bacteria culture from the intraoperative samples.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States