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Anti-biotic

Calcium Sulfate Antibiotic Depot for Open Tibia Fractures

Phase 3

Recruiting

Led By Rachel B Seymour, PhD

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

No Placebo-Only Group

Pivotal Trial

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6, month 3, month 6 and month12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants who develop deep surgical site infection (SSI)

Secondary study objectives

Average Time to Return to Work/Duty

International Physical Activity Questionnaire (IPAQ)

Number of Participants who Return to the Operating Room (OR)

+18 more

Awards & Highlights

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.

Trial 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

~1160

Do I qualify?Apply below to find out