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IO Vancomycin in TSA

Primary Purpose

Shoulder Injuries

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intervention - Intraosseous (IO) administration of vancomycin
Control - Standard IV administration of vancomycin
Sponsored by
The Methodist Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Injuries focused on measuring total shoulder arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Houston Methodist HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control - Standard IV administration of vancomycin

Intervention - Intraosseous (IO) administration of vancomycin

Arm Description

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).

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

Outcomes

Primary Outcome Measures

Levels of Vancomycin
Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups.

Secondary Outcome Measures

Post-operative Complication (infection) rates
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.

Full Information

First Posted
March 10, 2023
Last Updated
August 7, 2023
Sponsor
The Methodist Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05831774
Brief Title
IO Vancomycin in TSA
Official Title
Intraosseous vs. Intravenous Vancomycin Administration in Total Shoulder Arthroplasty: Changing the Paradigm
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
March 10, 2025 (Anticipated)
Study Completion Date
March 10, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Methodist Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Injuries
Keywords
total shoulder arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
2 groups - one control, one treatment
Masking
ParticipantInvestigator
Masking Description
Double blinded study
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control - Standard IV administration of vancomycin
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Intervention - Intraosseous (IO) administration of vancomycin
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Intervention - Intraosseous (IO) administration of vancomycin
Intervention Description
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 Type
Drug
Intervention Name(s)
Control - Standard IV administration of vancomycin
Intervention Description
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).
Primary Outcome Measure Information:
Title
Levels of Vancomycin
Description
Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Post-operative Complication (infection) rates
Description
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.
Time Frame
30 day, 90 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kendra Ihaza, MS
Phone
3462380206
Email
kihaza@houstonmethodist.org
First Name & Middle Initial & Last Name or Official Title & Degree
Haley Goble, MHA
Phone
7134413930
Email
hmgoble@houstonmethodist.org
Facility Information:
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haley Goble, MHA
Phone
713-441-3930
Email
hmgoble@houstonmethodist.org
First Name & Middle Initial & Last Name & Degree
Patrick C McCulloch, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share this information.

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IO Vancomycin in TSA

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