Osteoarthritis
Conditions
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.
Interventions
DRUGDoxycycline
The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision for total shoulder arthroplasty.
DRUGCefazolin
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing primary total shoulder arthroplasty at Rush University Medical Center
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Cefazolin | 27 |
| Doxycycline+Cefazolin Group 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: The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision for total shoulder arthroplasty.
Cefazolin | 29 |
| Total | 56 |
Baseline characteristics
| Characteristic | Cefazolin | Doxycycline+Cefazolin Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 19 Participants | 40 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 10 Participants | 16 Participants |
| Age, Continuous | 69 years STANDARD_DEVIATION 8 | 67 years STANDARD_DEVIATION 8 | 68 years STANDARD_DEVIATION 8 |
| Body Mass Index | 30 kg/m^2 STANDARD_DEVIATION 6 | 30 kg/m^2 STANDARD_DEVIATION 6 | 30 kg/m^2 STANDARD_DEVIATION 6 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 27 participants | 29 participants | 56 participants |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Male | 22 Participants | 27 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 29 |
| other Total, other adverse events | 0 / 27 | 0 / 29 |
| serious Total, serious adverse events | 0 / 27 | 0 / 29 |
Outcome results
Primary
Bacterial Culture
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.
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cefazolin | Bacterial Culture | 14 # Participants with Bacteria in Culture |
| Cefazolin and Doxycycline | Bacterial Culture | 15 # Participants with Bacteria in Culture |