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.
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
- Conditions the study is for
- Open tíbia Fracture, Osteomyelitis Tibia, Tibial Fractures
- 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
- 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
- Not yet recruiting
University of Kentucky
Lexington, Kentucky, 40508
Paul Matuszewski, MD
Matthew Eubank, BSN, mseuba01@uky.edu
- 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
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).
- Conditions
- Open tíbia Fracture, Osteomyelitis Tibia, Tibial Fractures
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vancomycin Hydrochloride; Drug: Gentamicin |
| Standard of care intramedullary nail (SN) | Other | Standard 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.
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)
Number of Participants who Return to the Operating Room (OR)
Number of Participants who Return to the Operating Room (OR)
Measured: Month 12
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
Time to Union
Captured in days
Measured: week 6, month 3, month 6 and month 12
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
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
Average Time to Return to Work/Duty
number of days
Measured: week 6, month 3, month 6 and month 12
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted13 Mar 2023
- Study start8 Apr 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open tíbia FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel B Seymour, PhD, Principal investigator, Wake Forest University Health SciencesJessica Rivera, MD, Principal investigator, Louisiana State University Health Science Center
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramedullary Calcium Sulfate Antibiotic Depot for Prevention of Open Fracture Related Infection: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05766670
- Acronym / sponsor ID
- W81XWH-22-10937
- Conditions
- Open tíbia Fracture, Osteomyelitis Tibia, Tibial Fractures
- Keywords
- antibiotic depot
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramedullary calcium sulfate antibiotic depot prior to Intramedullary nailing (IMN) placement (CS) | Other | Drug: Vancomycin Hydrochloride, Drug: GentamicinThe 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 of care intramedullary nail (SN) | Other | Other: Standard Intramedullary NailStandard of care intramedullary nail |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years and older
- Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vancomycin HydrochlorideAlso: antibacterial prescription medicineThe 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 | Intramedullary calcium sulfate antibiotic depot prior to Intramedullary nailing (IMN) placement (CS) |
| GentamicinAlso: injection is used to treat certain serious infections that are caused by bacteria such as meningitisThe 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 | Intramedullary calcium sulfate antibiotic depot prior to Intramedullary nailing (IMN) placement (CS) |
| Standard Intramedullary NailAlso: 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 boneStandard Intramedullary Nail | Other | Standard of care intramedullary nail (SN) |
Primary outcome
Number of participants who develop deep surgical site infection (SSI)
Time frame: Month 12
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.
21 secondary outcomes
Number of Participants who Return to the Operating Room (OR)
Time frame: Month 12
Percentage of Union
Time frame: week 6, month 3, month 6 and month 12
Time to Union
Time frame: week 6, month 3, month 6 and month 12
Radiographic Union Scale in Tibial fractures (RUST) score
Time frame: week 6, month 3, month 6, and month 12
Presence of drainage from incision and wounds
Time frame: week 6, month 3, month 6 and month 12
Average Time to Return to Work/Duty
Time frame: week 6, month 3, month 6 and month 12
International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline, 3 month, 6 month, 12 month
PROMIS-29 Subscale--Physical Function
Time frame: week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Physical Function: Anxiety
Time frame: week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Depression
Time frame: week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Fatigue
Time frame: week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Sleep Disturbance
Time frame: week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Pain Interference
Time frame: week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Ability to Participate in Social Roles and Activities
Time frame: week 6, month 3, month 6 and month12
Veterans RAND 12 Item Health Survey (VR-12) Domain --General Health
Time frame: week 6, month 3, month 6 and month12
Veterans RAND 12 Item Health Survey (VR-12) Domain--Physical Functioning
Time frame: week 6, month 3, month 6 and month12
Veterans RAND 12 Item Health Survey (VR-12) Domain--Role Limitations
Time frame: week 6, month 3, month 6 and month12
Veterans RAND 12 Item Health Survey (VR-12) Domain--Pain
Time frame: week 6, month 3, month 6 and month12
Veterans RAND 12 Item Health Survey (VR-12) Domain--Fatigue
Time frame: week 6, month 3, month 6 and month12
Veterans Rand 12 Item Health Survey (VR-12) Domain --Social Functioning
Time frame: week 6, month 3, month 6 and month12
Veterans Rand 12 Item Health Survey (VR-12) Domain--Mental Health
Time frame: week 6, month 3, month 6 and month12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel B Seymour, PhD principal investigator
Wake Forest University Health Sciences
Jessica Rivera, MD principal investigator
Louisiana State University Health Science Center
12 sites in 1 country: see every site and its status.
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.