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Anti-biotic
Calcium Sulfate Antibiotic Depot for Open Tibia Fractures
Phase 3
Waitlist Available
Led By Jessica Rivera, MD
Research Sponsored by Wake Forest University Health Sciences
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 week 6, month 3, month 6 and month12
Awards & highlights
Study Summary
This trial is studying if a new treatment can better prevent infection in people with lower leg fractures.
Who is the study for?
Adults over 18 with a Type II or III open tibia fracture needing an intramedullary nail can join. Excluded are those under 18, allergic to vancomycin/tobramycin, with high blood calcium levels, without contact info, prisoners, non-English/Spanish speakers, and pregnant or breastfeeding women.Check my eligibility
What is being tested?
The trial is testing if using calcium sulfate mixed with antibiotics (vancomycin hydrochloride or gentamicin) inside the bone is better at preventing infections compared to the usual treatment in patients with severe lower leg fractures.See study design
What are the potential side effects?
Possible side effects include allergic reactions to antibiotics used (vancomycin/gentamicin), issues related to high calcium levels due to the calcium sulfate depot and typical risks associated with surgery such as pain and infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 6, month 3, month 6 and month12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6, month 3, month 6 and month12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants who develop deep surgical site infection (SSI)
Secondary outcome measures
Average Time to Return to Work/Duty
International Physical Activity Questionnaire (IPAQ)
Number of Participants who Return to the Operating Room (OR)
+18 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Standard of care intramedullary nail (SN)Experimental Treatment1 Intervention
Standard of care intramedullary nail
Group II: Intramedullary calcium sulfate antibiotic depot prior to Intramedullary nailing (IMN) placement (CS)Experimental Treatment2 Interventions
The intramedullary calcium sulfate antibiotic depot will be mixed sterilely to include at minimum 20cc calcium sulfate powder mixed with 1g of vancomycin powder and 1.2g of tobramycin powder per 10cc of calcium sulfate.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gentamicin
2015
Completed Phase 4
~1110
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,240 Previous Clinical Trials
1,003,710 Total Patients Enrolled
1 Trials studying Open Tibia Fracture
484 Patients Enrolled for Open Tibia Fracture
Jessica Rivera, MDPrincipal InvestigatorLouisiana State University Health Science Center
Rachel B Seymour, PhDPrincipal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I cannot communicate in English or Spanish.I am 18 years old or older.I have a severe open fracture in my shinbone needing surgery with a metal rod.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of care intramedullary nail (SN)
- Group 2: Intramedullary calcium sulfate antibiotic depot prior to Intramedullary nailing (IMN) placement (CS)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
To what extent could this treatment pose a risk to participants?
"The safety of this treatment has been scored a 3 due to the wealth of evidence gathered from Phase 3 trials that suggest its efficacy and reliability."
Answered by AI
Is recruitment still open for this clinical experiment?
"As per clinicaltrials.gov, this trial is no longer accepting participants having been first posted on October 1st 2023 and last updated April 5th of the same year. But fret not; there are 381 other medical studies actively seeking volunteers at present."
Answered by AI
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