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Open tíbia FracturePhase 3NCT05766670

Intramedullary Calcium Sulfate Antibiotic Depot

A Phase 3 study testing Vancomycin Hydrochloride, Gentamicin and Standard Intramedullary Nail in people with Open tíbia Fracture and Osteomyelitis Tibia, run by Wake Forest University Health Sciences at 12 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Vancomycin Hydrochloride, Gentamicin and Standard Intramedullary Nail
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
242 participants
Where
12 sitesUnited States
Study dates
8 Apr 2024to Jan 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

12 sites in 1 country

United States12 sites, 12 recruiting
  • Atrium Health Carolinas Medical Center

    Charlotte, North Carolina, 28204

    Joseph Hsu, MD, joseph.hsu@atriumhealth.org

    Christine Churchill, MA, Christine.Churchill@advocatehealth.org

    Recruiting
  • University of Chicago

    Chicago, Illinois, 60637

    Ashley Mayo, 773-906-4605, Ashley.Mayo@bsd.uchicago.edu

    Brianna Fram, MD

    Recruiting
  • Atrium Health Cabarrus

    Concord, North Carolina, 28025

    Luke Harmer, MD, Luke.Harmer@atriumhealth.org

    Erica Grochowski, MPH, Erica.Grochowski@advocatehealth.org

    Recruiting
  • Pennsylvania State University

    Hershey, Pennsylvania, 17033

    Jana Davis, MD

    Andrea Myers, amyers1@pennstatehealth.psu.edu

    Recruiting
  • University of Kentucky

    Lexington, Kentucky, 40508

    Paul Matuszewski, MD

    Matthew Eubank, BSN, mseuba01@uky.edu

    Not yet recruiting
  • Cedars-Sinai

    Los Angeles, California, 90048

    Geoffrey Marecek, MD

    Joel Arnold, joel.arnold@cshs.org

    Recruiting
  • Atrium Health Navicent The Medical Center

    Macon, Georgia, 31201

    Jarrod Dumpe, MD, jarrod.dumpe@atriumhealth.org

    Adithi Shyam, Adithi.Shyam@Advocatehealth.org

    Recruiting
  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    William Obremskey

    Karen Trochez, karen.m.trochez@vumc.org

    Recruiting
  • Louisiana State University Health Sciences Center

    New Orleans, Louisiana, 70112

    Jessica Rivera, MD, jriv5@lsuhsc.edu

    Carolyn Bridgman, cbrid5@lsuhsc.edu

    Recruiting
  • Carilion Clinic

    Roanoke, Virginia, 24016

    Garret Burks, PhD, 540-526-1157, wgburks@carilionclinic.org

    Cody Evans, MD

    Recruiting
  • Valley Health

    Winchester, Virginia, 22601

    Ken Nelson, MD

    Ashley Zelaski, azelaski2@valleyhealthlink.com

    Recruiting
  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

    Christine Churchill, MA, 704-355-2000, Christine.Churchill@advocatehealth.org

    Rachel B Seymour, PhD

    Recruiting

Other trials in United States

About this study

Official title: Intramedullary Calcium Sulfate Antibiotic Depot for Prevention of Open Fracture Related Infection: A Randomized Clinical Trial

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.

Read the detailed description

This research is a randomized clinical trial aimed to reduce the frequency of fracture related infections following open tibia fracture. The proposed test methods for infection reduction is use of an antibiotic depot placed inside the bone at the time of final fracture treatment. This is in addition to standard of care wound care, fracture fixation with intramedullary nailing, and peri-operative systemic antibiotics.

This prospective randomized clinical trial will compare outcomes between patients treated with an antibiotic depot placed inside the bone at the time of final fracture fixation and those treated with traditional standard of care intramedullary nailing.

The target population for the proposed study is patients with severe open tibia fractures (Type II or III) who require definitive fixation with intramedullary nail recruited form one of the participating sites during the index hospitalization.

One group will be treated prophylactically suing a calcium sulfate antibiotic depot at the time of definitive fixation, while the second group will be treated with a standard of care intramedullary nail without the antibiotic depot.

Participants will be followed for 12 months (data capture includes patient interviews and clinical data capture from the treatment team and medical record at baseline, 6 weeks, 3 months, 6 months, and 12 months).

Being tested
Vancomycin Hydrochloride, Gentamicin, Standard Intramedullary Nail
Keywords
antibiotic depot
Medical subject headings
Tibial Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vancomycin HydrochlorideDrug

    Also called antibacterial prescription medicine

    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.

  • GentamicinDrug

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

    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 NailOther

    Also called 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 Intramedullary Nail

Study groups in NCT05766670
Study groupRoleWhat they receive
Intramedullary calcium sulfate antibiotic depot prior to Intramedullary nailing (IMN) placement (CS)OtherThe 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.
Receives: Drug: Vancomycin Hydrochloride; Drug: Gentamicin
Standard of care intramedullary nail (SN)OtherStandard of care intramedullary nail
Receives: Other: Standard Intramedullary Nail

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Month 12

Secondary outcomes (21)
  1. Number of Participants who Return to the Operating Room (OR)

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

    Measured: Month 12

  2. Percentage of Union

    Union is the gradual process of bone regeneration after a fracture. Percentage of Union, as determined by the treating surgeon, will be assessed via radiographs. Recorded by surgeon as yes/no answers.

    Measured: week 6, month 3, month 6 and month 12

  3. Time to Union

    Captured in days

    Measured: week 6, month 3, month 6 and month 12

  4. Radiographic Union Scale in Tibial fractures (RUST) score

    The RUST score ranges from a minimum score of 4 (definitely not healed) to a maximum score of 12 (completely healed). The final x-ray obtained within a 12-month period following injury will be uploaded to REDCap for review by a blinded panel of investigators from participating sites.

    Measured: week 6, month 3, month 6, and month 12

  5. Presence of drainage from incision and wounds

    When present, patients will be asked to document the duration of drainage. Duration will be treated as a continuous variable with 7 days of drainage categorized as "persistent drainage".

    Measured: week 6, month 3, month 6 and month 12

  6. Average Time to Return to Work/Duty

    number of days

    Measured: week 6, month 3, month 6 and month 12

  7. International Physical Activity Questionnaire (IPAQ)

    IPAQ measures the total amount of physical activity completed in a 7 day period by calculating the minutes per week in in each physical activity level domain (walking, moderate and vigorous) by a metabolic equivalent energy (MET) expenditure estimate.

    Walking = 3.3 x number of walking minutes x number of walking days Moderate activity= 4.0 x number activity minutes x number of days Vigorous activity = 8 x number of activity minutes x number of days Total = Walking MET-min/wk+moderate MET-min/wk+vigorous MET-min/wk

    Measured: Baseline, 3 month, 6 month, 12 month

  8. PROMIS-29 Subscale--Physical Function

    The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. The sum of the PROMIS results in the raw score, which lies between 4 and 20 - Higher scores means higher physical function; lower scores represent lower physical function

    Measured: week 6, month 3, month 6 and month12

  9. PROMIS-29 Subscale--Physical Function: Anxiety

    The PROMIS-29 scales will be scored using a T-score metric method. The PROMIS Anxiety item banks assess self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of anxiety; lower scores represent lower level of anxiety

    Measured: week 6, month 3, month 6 and month12

  10. PROMIS-29 Subscale--Depression

    The PROMIS-29 scales will be scored using a T-score metric method. For each scale, respondents are asked how often in the past 7 days they have experienced specific depression symptoms, using a 5-point ordinal rating scale of "Never," "Rarely," "Sometimes," "Often," and "Always." A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of depression; lower scores represent lower level of depression

    Measured: week 6, month 3, month 6 and month12

  11. PROMIS-29 Subscale--Fatigue

    The PROMIS-29 scales will be scored using a T-score metric method. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like fatigue, a T-score of 60 is one SD worse than average. By comparison, a fatigue T-score of 40 is one Standard Deviation better than average. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of fatigue. Mean fatigue scores in the four study samples ranged from 18.5 to 22.8 on the PROMIS (PROMIS) Fatigue-Short Form (F-SF) (potential range 7-35); from 14.8 to 47.8 on the MFSI-SF (potential range 24-86); and from 3.6 to 6.6 on the BFI (potential range 0-10).

    Measured: week 6, month 3, month 6 and month12

  12. PROMIS-29 Subscale--Sleep Disturbance

    The PROMIS-29 scales will be scored using a T-score metric method. The PROMIS Sleep Disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of sleep disturbance. Total score is the sum of the seven subscale scores (ie, quality of sleep, quantity of sleep, sleep onset latency, midsleep awakenings, early awakenings, medications for sleep, excessive daytime sleepiness) that can range from 0 (no disturbance) to 147 (extreme sleep disturbance).

    Measured: week 6, month 3, month 6 and month12

  13. PROMIS-29 Subscale--Pain Interference

    The PROMIS-29 scales will be scored using a T-score metric method. PROMIS Pain Intensity T-scores from 20-55 are considered within normal limits, 55-60 is mild, 60-70 is moderate, and 70+ is severe. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of pain interference. PROMIS Pain Interference (PROMIS-PI) scale measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities.

    Measured: week 6, month 3, month 6 and month12

  14. PROMIS-29 Subscale--Ability to Participate in Social Roles and Activities

    The PROMIS-29 scales will be scored using a T-score metric method. Social function is defined by PROMIS as involvement in, and satisfaction with, one's usual social roles in life's situations and activities. These roles may exist in marital relationships, parental responsibilities, work responsibilities and social activities. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher ability to participate in social roles and activities.

    Measured: week 6, month 3, month 6 and month12

  15. Veterans RAND 12 Item Health Survey (VR-12) Domain --General Health

    The VR-12 is a measure of global health that correspond to seven domains. Together, these items are summarized into a Physical Component Score and a Mental Component Score. The VR-12 is a patient-reported instrument from which physical and mental health component summary scores (PCS and MCS) are derived. The PCS and MCS are normalized using TScore and are on a 0-100 scale. The interpretation is based on a population mean of 50 and standard deviation of 10. Higher scores represent a better outcome. The VR-12 items assess physical functioning, role limitations due to physical or mental health problems, pain, energy, mental health, social functioning, and general health.

    Measured: week 6, month 3, month 6 and month12

  16. Veterans RAND 12 Item Health Survey (VR-12) Domain--Physical Functioning

    The VR-12 is a measure of global health that correspond to seven domains. Together, these items are summarized into a Physical Component Score and a Mental Component Score. The VR-12 is a patient-reported instrument from which physical and mental health component summary scores (PCS and MCS) are derived. The PCS and MCS are normalized using TScore and are on a 0-100 scale. The interpretation is based on a population mean of 50 and standard deviation of 10. Higher scores represent a better outcome. The VR-12 items assess physical functioning, role limitations due to physical or mental health problems, pain, energy, mental health, social functioning, and general health.

    Measured: week 6, month 3, month 6 and month12

  17. Veterans RAND 12 Item Health Survey (VR-12) Domain--Role Limitations

    The VR-12 is a measure of global health that correspond to seven domains. Together, these items are summarized into a Physical Component Score and a Mental Component Score. The PCS and MCS are normalized using TScore and are on a 0-100 scale. The interpretation is based on a population mean of 50 and standard deviation of 10. Higher scores represent a better outcome.

    Measured: week 6, month 3, month 6 and month12

  18. Veterans RAND 12 Item Health Survey (VR-12) Domain--Pain

    The VR-12 is a measure of global health that correspond to seven domains. Together, these items are summarized into a Physical Component Score and a Mental Component Score. The PCS and MCS are normalized using TScore and are on a 0-100 scale. The interpretation is based on a population mean of 50 and standard deviation of 10. Higher scores represent a better outcome.

    Measured: week 6, month 3, month 6 and month12

  19. Veterans RAND 12 Item Health Survey (VR-12) Domain--Fatigue

    The VR-12 is a measure of global health that correspond to seven domains. Together, these items are summarized into a Physical Component Score and a Mental Component Score. The PCS and MCS are normalized using TScore and are on a 0-100 scale. The interpretation is based on a population mean of 50 and standard deviation of 10. Higher scores represent a better outcome.

    Measured: week 6, month 3, month 6 and month12

  20. Veterans Rand 12 Item Health Survey (VR-12) Domain --Social Functioning

    The VR-12 is a measure of global health that correspond to seven domains. Together, these items are summarized into a Physical Component Score and a Mental Component Score. The PCS and MCS are normalized using TScore and are on a 0-100 scale. The interpretation is based on a population mean of 50 and standard deviation of 10. Higher scores represent a better outcome.

    Measured: week 6, month 3, month 6 and month12

  21. Veterans Rand 12 Item Health Survey (VR-12) Domain--Mental Health

    The VR-12 is a measure of global health that correspond to seven domains. Together, these items are summarized into a Physical Component Score and a Mental Component Score. The PCS and MCS are normalized using TScore and are on a 0-100 scale. The interpretation is based on a population mean of 50 and standard deviation of 10. Higher scores represent a better outcome.

    Measured: week 6, month 3, month 6 and month12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2023
  2. Study start8 Apr 2024
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
242 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05766670
Sponsor's protocol ID
W81XWH-22-10937
Other IDs
W81XWH-22-10937
Status last verified
Oct 2026
First submitted
27 Feb 2023
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vancomycin Hydrochloride, Gentamicin and Standard Intramedullary Nail in people with Open tíbia Fracture and Osteomyelitis Tibia, run by Wake Forest University Health Sciences at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christine Churchill, MA (7043552000, christine.churchill@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who develop deep surgical site infection (SSI) (time frame: Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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