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Antibiotic
IO vs IV Vancomycin for Preventing Infection in Shoulder Surgery
Phase 4
Recruiting
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 day, 90 day
Awards & highlights
Study Summary
This trial will compare two antibiotics and techniques used during shoulder surgery to investigate infection rates.
Who is the study for?
This trial is for adults over 18 who are having shoulder replacement surgery and can consent to the study. It's not for those with past shoulder surgeries, allergies to certain antibiotics like vancomycin, or conditions that make IO infusion impossible. People with diabetes, weakened immune systems, or a BMI above 35 are also excluded.Check my eligibility
What is being tested?
The study compares two ways of giving the antibiotic vancomycin during shoulder surgery: through IV (control) and directly into the bone (IO). The goal is to see if both methods deliver similar drug levels in tissues and have comparable infection rates after surgery at 30 and 90 days.See study design
What are the potential side effects?
Potential side effects include typical reactions to vancomycin such as skin rashes, redness, kidney issues when given via IV; IO administration may cause local discomfort or complications related to bone infusion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 day, 90 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 day, 90 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Levels of Vancomycin
Secondary outcome measures
Post-operative Complication (infection) rates
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention - Intraosseous (IO) administration of vancomycinExperimental Treatment1 Intervention
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
Group II: Control - Standard IV administration of vancomycinPlacebo Group1 Intervention
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).
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Who is running the clinical trial?
The Methodist Hospital Research InstituteLead Sponsor
271 Previous Clinical Trials
80,335 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having shoulder replacement surgery.I am older than 18 years.I have a weakened immune system due to a condition or treatment.I have had shoulder surgery before.My BMI is over 35.I cannot take certain antibiotics like vancomycin or cefepime due to allergies or other issues.I cannot receive treatments through IV.I do not wish to participate in the trial.I have diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Control - Standard IV administration of vancomycin
- Group 2: Intervention - Intraosseous (IO) administration of vancomycin
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the Food and Drug Administration sanction Intraosseous (IO) delivery of vancomycin?
"This medical treatment has already been approved, which is why it earned a score of 3 for safety. Intervention - Intraosseous (IO) administration of vancomycin was part of a Phase 4 trial."
Answered by AI
Is this research endeavor seeking participants at present?
"Affirmative, clinicaltrials.gov indicates that this medical experiment is actively searching for volunteers. This research was first posted on April 25th 2023 and has been updated most recently on the 14th of same month. Researchers are looking to recruit 40 participants from a single site."
Answered by AI
What is the aggregate size of individuals participating in this research initiative?
"Affirmative. Documentation available on clinicaltrials.gov confirms that this experiment is currently looking for volunteers, with 40 participants needed at a single location since it was first posted in April 25th 2023 and last updated 14 days later."
Answered by AI
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