IO Vancomycin in TSA

Conditions

Shoulder Injuries

Keywords

total shoulder arthroplasty

Brief summary

The purpose of this study is to compare two different antibiotic regimens and techniques during total shoulder arthroplasty. Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups. Secondary Objective: 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.

Detailed description

This study is a prospective, randomized, single-blinded, controlled trial. 20 patients in each treatment arm: 20 patients will be given IV vancomycin, 20 patients will be given IO vancomycin. This sample size is based on previous studies examining vancomycin concentration in tourniquetless primary total knee arthroplasty between IO vs IV \[12,13\]. Once the participant has been enrolled, they will be randomized into either the control group or the experimental group by an excel-based software program prior to their procedure. Control - Standard IV administration of vancomycin 1\) 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 1. IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision 2. IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS). 3. Injection will take place into the proximal humerus All patients in both groups will be monitored during the surgery and immediately post-operatively for adverse injection reactions (i.e. Red Man Syndrome) as this is the standard of care. All patients (IV and IO) will otherwise follow identical post-operative protocols (including post-operative antibiotic administration) Intra-Op Sample Collection Samples will be taken from the following locations at the following times: Systemic Sample - Start of Case A vancomycin blood level will be drawn by the anesthesiologist staff (CRNA, MD) at the start of incision and should occur simultaneously with the final soft tissue sample collection below Soft tissue sample - Synovium Start A small soft tissue sample will be taken from the synovium upon entering the shoulder joint. This sample will only be taken if it is readily available for the surgeon to gather. Bone Sample - Bone from Humeral Head After the humeral neck is cut with the cookie cutter instrument a portion of humeral head/neck will be removed and placed in a separate specimen jar (remainder of head will be sent to pathology as usual). Soft Tissue Sample - Synovium End A small soft tissue sample will be taken from the synovium prior to initiation of wound closure. This sample will only be taken if it is readily available for the surgeon to gather. Systemic Sample A vancomycin blood level will be drawn by the anesthesiologist staff (CRNA, MD) at the time of initiation of closure and should occur simultaneously with the final soft tissue sample collection above Data Variables to be Recorded Age (calculated from DOB), date of surgery, discharge date, sex, laterality, study group, pre-op creatinine, post-op creatinine, systemic vancomycin level at incision, soft tissue vancomycin level (synovium start and synovium end), humeral head bone sample vancomycin level, and systemic vancomycin level at initiation of wound closure. Additionally, adverse local/systemic reactions as determined from patient's chart, 30-day complications, 90-day complications, cost, time from antibiotic administration to incision, operative time, and incision time.

Related papers

No related papers found yet.

Interventions

DRUGIntervention - 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

DRUGControl - 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Double blinded study

Intervention model description

2 groups - one control, one treatment

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Patient is undergoing anatomic or reverse shoulder arthroplasty * Patient is able to give informed consent to participate on the study. LAR consents will not be utilized for this study * Age Range \>18

Exclusion criteria

* Previous shoulder surgery * BMI above 35 * Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc). * Inability to administer the IO infusion * Refusal to participate * Diabetes * Immunocompromised or immunosuppressed patients (HIV, Hep C, ESRD, dialysis, transplant, chemo/radiation treatment in last 6 months, medications)

Design outcomes

Primary

Measure	Time frame	Description
Vancomycin Levels in Bicep Tendon	24 hours	Comparable levels of vancomycin will be found in bicep tendon samples between patient groups.
Systemic Levels of Vancomycin	24 hours	Comparable levels of vancomycin will be found in systemic samples between patient groups.
Vancomycin Levels in the Initial Deltoid	24 hours	Comparable levels of vancomycin will be found in the initial deltoid samples between patient groups.
Vancomycin Levels in the Humeral Head	24 hours	Comparable levels of vancomycin will be found in humeral head samples between patient groups.
Levels of Vancomycin in Synovium	24 hours	Comparable levels of vancomycin will be found in synovium samples between patient groups.
Levels of Vancomycin in Labrum	24 hours	Comparable levels of vancomycin will be found in labrum samples between patient groups.
Levels of Vancomycin in Glenoid Reaming	24 hours	Comparable levels of vancomycin will be found in glenoid reaming samples between patient groups.
Levels of Vancomycin in Bicep Tendon	24 hours	Comparable levels of vancomycin will be found in bicep tendon samples between patient groups.
Levels of Vancomycin in End Deltoid	24 hours	Comparable levels of vancomycin will be found in end deltoid samples between patient groups.

Secondary

Measure	Time frame	Description
Post-operative Complication (Infection) Rates	30 days, 90 days	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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).	18
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	15
Total	33

Baseline characteristics

Characteristic	Control - Standard IV Administration of Vancomycin	Intervention - Intraosseous (IO) Administration of Vancomycin	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	12 Participants	12 Participants	24 Participants
Age, Categorical Between 18 and 65 years	6 Participants	3 Participants	9 Participants
Race and Ethnicity Not Collected	—	—	0 Participants
Sex: Female, Male Female	8 Participants	5 Participants	13 Participants
Sex: Female, Male Male	10 Participants	10 Participants	20 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 18	0 / 15
other Total, other adverse events	0 / 18	0 / 15
serious Total, serious adverse events	0 / 18	0 / 15

Outcome results

Primary