Trial Outcomes & Findings for IO Vancomycin in TSA (NCT NCT05831774)
NCT ID: NCT05831774
Last Updated: 2025-09-22
Results Overview
Comparable levels of vancomycin will be found in systemic samples between patient groups.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE4
Target enrollment
33 participants
Primary outcome timeframe
24 hours
Results posted on
2025-09-22
Participant Flow
Participant milestones
| Measure |
Control - Standard IV Administration of Vancomycin
Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
Control - Standard IV administration of vancomycin: Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
|
Intervention - Intraosseous (IO) Administration of Vancomycin
* IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
Intervention - Intraosseous (IO) administration of vancomycin: • IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
15
|
|
Overall Study
COMPLETED
|
18
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control - Standard IV Administration of Vancomycin
n=18 Participants
Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
Control - Standard IV administration of vancomycin: Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
|
Intervention - Intraosseous (IO) Administration of Vancomycin
n=15 Participants
* IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
Intervention - Intraosseous (IO) administration of vancomycin: • IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=33 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=18 Participants
|
3 Participants
n=15 Participants
|
9 Participants
n=33 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=18 Participants
|
12 Participants
n=15 Participants
|
24 Participants
n=33 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=18 Participants
|
5 Participants
n=15 Participants
|
13 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=18 Participants
|
10 Participants
n=15 Participants
|
20 Participants
n=33 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained.
Comparable levels of vancomycin will be found in systemic samples between patient groups.
Outcome measures
| Measure |
Control - Standard IV Administration of Vancomycin
n=17 Participants
Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
Control - Standard IV administration of vancomycin: Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
|
Intervention - Intraosseous (IO) Administration of Vancomycin
n=15 Participants
* IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
Intervention - Intraosseous (IO) administration of vancomycin: • IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
|
|---|---|---|
|
Systemic Levels of Vancomycin
|
23.65 ug/mL
Standard Error 3.85
|
9.79 ug/mL
Standard Error 0.52
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained.
Comparable levels of vancomycin will be found in the initial deltoid samples between patient groups.
Outcome measures
| Measure |
Control - Standard IV Administration of Vancomycin
n=17 Participants
Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
Control - Standard IV administration of vancomycin: Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
|
Intervention - Intraosseous (IO) Administration of Vancomycin
n=15 Participants
* IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
Intervention - Intraosseous (IO) administration of vancomycin: • IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
|
|---|---|---|
|
Vancomycin Levels in the Initial Deltoid
|
32.7 ug/mL
Standard Error 4.48
|
31.09 ug/mL
Standard Error 3.84
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained.
Comparable levels of vancomycin will be found in humeral head samples between patient groups.
Outcome measures
| Measure |
Control - Standard IV Administration of Vancomycin
n=17 Participants
Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
Control - Standard IV administration of vancomycin: Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
|
Intervention - Intraosseous (IO) Administration of Vancomycin
n=15 Participants
* IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
Intervention - Intraosseous (IO) administration of vancomycin: • IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
|
|---|---|---|
|
Vancomycin Levels in the Humeral Head
|
69.53 ug/mL
Standard Error 7.71
|
66.5 ug/mL
Standard Error 8.18
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained.
Comparable levels of vancomycin will be found in synovium samples between patient groups.
Outcome measures
| Measure |
Control - Standard IV Administration of Vancomycin
n=17 Participants
Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
Control - Standard IV administration of vancomycin: Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
|
Intervention - Intraosseous (IO) Administration of Vancomycin
n=15 Participants
* IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
Intervention - Intraosseous (IO) administration of vancomycin: • IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
|
|---|---|---|
|
Levels of Vancomycin in Synovium
|
34.96 ug/mL
Standard Error 5.55
|
31.1 ug/mL
Standard Error 4.7
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained.
Comparable levels of vancomycin will be found in labrum samples between patient groups.
Outcome measures
| Measure |
Control - Standard IV Administration of Vancomycin
n=17 Participants
Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
Control - Standard IV administration of vancomycin: Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
|
Intervention - Intraosseous (IO) Administration of Vancomycin
n=15 Participants
* IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
Intervention - Intraosseous (IO) administration of vancomycin: • IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
|
|---|---|---|
|
Levels of Vancomycin in Labrum
|
85 ug/mL
Standard Error 10.87
|
63.54 ug/mL
Standard Error 6.84
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained.
Comparable levels of vancomycin will be found in glenoid reaming samples between patient groups.
Outcome measures
| Measure |
Control - Standard IV Administration of Vancomycin
n=17 Participants
Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
Control - Standard IV administration of vancomycin: Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
|
Intervention - Intraosseous (IO) Administration of Vancomycin
n=15 Participants
* IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
Intervention - Intraosseous (IO) administration of vancomycin: • IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
|
|---|---|---|
|
Levels of Vancomycin in Glenoid Reaming
|
67.97 ug/mL
Standard Error 9.63
|
68.52 ug/mL
Standard Error 8.92
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained.
Comparable levels of vancomycin will be found in bicep tendon samples between patient groups.
Outcome measures
| Measure |
Control - Standard IV Administration of Vancomycin
n=17 Participants
Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
Control - Standard IV administration of vancomycin: Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
|
Intervention - Intraosseous (IO) Administration of Vancomycin
n=15 Participants
* IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
Intervention - Intraosseous (IO) administration of vancomycin: • IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
|
|---|---|---|
|
Levels of Vancomycin in Bicep Tendon
|
95.25 ug/mL
Standard Error 12.54
|
63 ug/mL
Standard Error 9.05
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained.
Comparable levels of vancomycin will be found in end deltoid samples between patient groups.
Outcome measures
| Measure |
Control - Standard IV Administration of Vancomycin
n=17 Participants
Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
Control - Standard IV administration of vancomycin: Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
|
Intervention - Intraosseous (IO) Administration of Vancomycin
n=15 Participants
* IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
Intervention - Intraosseous (IO) administration of vancomycin: • IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
|
|---|---|---|
|
Levels of Vancomycin in End Deltoid
|
43.23 ug/mL
Standard Error 5.48
|
38.68 ug/mL
Standard Error 5.47
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained.
Comparable levels of vancomycin will be found in bicep tendon samples between patient groups.
Outcome measures
| Measure |
Control - Standard IV Administration of Vancomycin
n=17 Participants
Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
Control - Standard IV administration of vancomycin: Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
|
Intervention - Intraosseous (IO) Administration of Vancomycin
n=15 Participants
* IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
Intervention - Intraosseous (IO) administration of vancomycin: • IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
|
|---|---|---|
|
Vancomycin Levels in Bicep Tendon
|
95.25 ug/mL
Standard Error 12.54
|
63 ug/mL
Standard Error 9.05
|
SECONDARY outcome
Timeframe: 30 days, 90 daysPopulation: Please note that these numbers will differ from the participant flow module because one sample from one of the participants was not usable. There was a processing error with the sample in the lab, so values were not obtained.
Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups.
Outcome measures
| Measure |
Control - Standard IV Administration of Vancomycin
n=17 Participants
Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
Control - Standard IV administration of vancomycin: Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[6,7\] generally 1000-1750mg in 500mL NS).
|
Intervention - Intraosseous (IO) Administration of Vancomycin
n=15 Participants
* IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
Intervention - Intraosseous (IO) administration of vancomycin: • IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
* Injection will take place into the proximal humerus
|
|---|---|---|
|
Post-operative Complication (Infection) Rates
30 Days Post-Op
|
1 Postoperative Complications
|
0 Postoperative Complications
|
|
Post-operative Complication (Infection) Rates
90 Days Post-Op
|
0 Postoperative Complications
|
0 Postoperative Complications
|
Adverse Events
Control - Standard IV Administration of Vancomycin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention - Intraosseous (IO) Administration of Vancomycin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place