Recruiting
Phase 3

Calcium Sulfate

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05766670

Conditions

Open tíbia Fracture

Osteomyelitis Tibia

Tibial Fractures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vancomycin Hydrochloride

Gentamicin

Standard Intramedullary Nail

Study Details

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

Study ID

NCT05766670

Start date

Apr 8, 2024

Status verified date

Oct, 2025

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

497 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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

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.

other: Standard of care intramedullary nail (SN)

Standard of care intramedullary nail

Interventions

Vancomycin Hydrochloride

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.

Gentamicin

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.

Standard Intramedullary Nail

Standard Intramedullary Nail

Primary outcome measure

  • Number of participants who develop deep surgical site infection (SSI) [ Time Frame: Month 12 ]

Central Contacts and Locations

Central contacts

Christine Churchill, MA

7043552000christine.churchill@atriumhealth.org

Rachel B Seymour, PhD

7043552000rachel.seymour@atriumhealth.org

Locations

Cedars-Sinai

Recruiting

Los Angeles, California, United States, 90048

Contacts

Joel Arnold

joel.arnold@cshs.org

Principal Investigator:

Geoffrey Marecek, MD

Atrium Health Navicent The Medical Center

Recruiting

Macon, Georgia, United States, 31201

Contacts

Jarrod Dumpe, MD

jarrod.dumpe@atriumhealth.org

Adithi Shyam

Adithi.Shyam@Advocatehealth.org

Louisiana State University Health Sciences Center

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Jessica Rivera, MD

jriv5@lsuhsc.edu

Carolyn Bridgman

cbrid5@lsuhsc.edu

Atrium Health Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Joseph Hsu, MD

joseph.hsu@atriumhealth.org

Christine Churchill, MA

christine.churchill@atriumhealth.org

Atrium Health Cabarrus

Recruiting

Concord, North Carolina, United States, 28025

Contacts

Luke Harmer, MD

Luke.Harmer@atriumhealth.org

Erica Grochowski, MPH

erica.grochowski@atriumhealth.org

Atrium Health Wake Forest Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Christine Churchill, MA

704-355-2000christine.churchill@atriumhealth.org

Principal Investigator:

Rachel B Seymour, PhD

Pennsylvania State University

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Andrea Myers

amyers1@pennstatehealth.psu.edu

Principal Investigator:

Jana Davis, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Karen Trochez

karen.m.trochez@vumc.org

Principal Investigator:

William Obremskey, MD

Valley Health

Recruiting

Winchester, Virginia, United States, 22601

Contacts

Ashley Zelaski

azelaski2@valleyhealthlink.com

Principal Investigator:

Ken Nelson, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 7, 2026

Last verified

Oct, 2025

Keywords

  • antibiotic depot

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-07.