Intramedullary Calcium Sulfate Antibiotic Depot

NCT05766670 | Recruiting Phase 3 FDA Drug

• 1 other identifier: W81XWH-22-10937
• Study Type: interventional
• Target: 497
• Locations: 1 country
• Sites: 10

Brief Summary

The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care.

Conditions

Open tíbia Fracture; Osteomyelitis Tibia; Tibial Fractures

Keywords

antibiotic depot

Outcome Measures

Primary Outcomes (1)

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

  Number of participants in each group who develop surgical site infection (SSI) as defined by the criteria establish by the Centers for Disease Control and Prevention (CDC). The CDC criteria define deep as occurring within 30 or 90 days after the procedure. However, we will continue to follow patients for 12 months and document any infections and other complications during this period.

  Month 12

Secondary Outcomes (21)

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

  Month 12

• Percentage of Union

  week 6, month 3, month 6 and month 12

• Time to Union

  week 6, month 3, month 6 and month 12

• Radiographic Union Scale in Tibial fractures (RUST) score

  week 6, month 3, month 6, and month 12

• Presence of drainage from incision and wounds

  week 6, month 3, month 6 and month 12

Study Arms (2)

Intramedullary calcium sulfate antibiotic depot prior to Intramedullary nailing (IMN) placement (CS)

OTHER

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.

Drug: Vancomycin Hydrochloride; Drug: Gentamicin

Standard of care intramedullary nail (SN)

OTHER

Standard of care intramedullary nail

Other: Standard Intramedullary Nail

Interventions

Gentamicin DRUG

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.

Also known as: injection is used to treat certain serious infections that are caused by bacteria such as meningitis

Intramedullary calcium sulfate antibiotic depot prior to Intramedullary nailing (IMN) placement (CS)

Standard Intramedullary Nail OTHER

Standard Intramedullary Nail

Also known as: metal rod that is inserted into the medullary cavity of a bone and across the fracture in order to provide a solid support for the fractured bone

Standard of care intramedullary nail (SN)

Vancomycin Hydrochloride DRUG

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.

Also known as: antibacterial prescription medicine

Intramedullary calcium sulfate antibiotic depot prior to Intramedullary nailing (IMN) placement (CS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years and older
• Type II or III open tibia fracture requiring definitive fixation with intramedullary nail

You may not qualify if:

• Less than 18 years of age
• Allergy to vancomycin or tobramycin
• Hypercalcemia
• Unable to speak English or Spanish
• No email, phone, or other point of contact
• Pregnant and lactating women
• Prisoner

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (10)

Cedars-Sinai

Los Angeles, California, 90048, United States

RECRUITING

Atrium Health Navicent The Medical Center

Macon, Georgia, 31201, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, 40508, United States

NOT YET RECRUITING

Louisiana State University Health Sciences Center

New Orleans, Louisiana, 70112, United States

RECRUITING

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

RECRUITING

Atrium Health Cabarrus

Concord, North Carolina, 28025, United States

RECRUITING

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Pennsylvania State University

Hershey, Pennsylvania, 17033, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

NOT YET RECRUITING

Valley Health

Winchester, Virginia, 22601, United States

RECRUITING

MeSH Terms

Conditions

Tibial Fractures

Interventions

Vancomycin; Gentamicins

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Aminoglycosides; Glycosides

Study Officials

• Rachel B Seymour, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Jessica Rivera, MD

  Louisiana State University Health Science Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Churchill, MA

CONTACT

7043552000; christine.churchill@atriumhealth.org

Rachel B Seymour, PhD

CONTACT

7043552000; rachel.seymour@atriumhealth.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 13, 2023
• Study Start: April 8, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)