Fracture of TibiaPhase 3iVACNCT06337292
Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures
A Phase 3 study testing Incisional Negative Pressure Wound Therapy (NPWT) in people with Fracture of Tibia and Wound Heal, run by Major Extremity Trauma Research Consortium at 6 sites in United States.
Trial summary
This is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision >3cm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Tibia, Wound Heal, Infected Wound
- What is being tested?
- Incisional Negative Pressure Wound Therapy (NPWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Jan 2025to 31 Dec 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
- All open or closed tibial plateau or pilon fractures treated operatively with internal fixation at high risk for complication. Any open Gustilo Type I, II or IIIA tibial shaft fracture treated definitively with internal or external fixation with or without ipsilateral leg compartment syndrome if at least one wound is primarily closed.
- We define high-risk fractures as those that are either:
- Closed fracture initially treated with an external fixator (with or without limited internal fixation) and treated definitive more than 3 days later after swelling has resolved;
- Any open type I, II or IIIA fracture, regardless of timing of definitive treatment;
- Any tibial plateau fracture associated with ipsilateral leg compartment syndrome fasciotomy wounds that has at least one wound primarily closed
- Requiring incision for fixation or debridement of 3 cm or greater.
- Patients 18 years of age or older
Who cannot join
- The study injury is already infected at time of study enrollment.
- Patient is unable to receive incisional NPWT for any reason.
- Patients who have already had definitive fixation prior to enrollment in the study.
- Severe problems with maintaining follow-up (e.g., patients who are homeless at the time of injury or those who are intellectually challenged without adequate family support or who are prisoners).
- The study injury is a Gustilo Type IIIB or IIIC open fracture.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
Robert O'Toole, MD
- Recruiting
University of Maryland Shock Trauma/Capitol Regions
Baltimore, Maryland, 21201
Yasmin Degani, (410) 706-5917, ydegani@som.umaryland.edu
- Recruiting
Inova Fairfax MEdical Campus
Falls Church, Virginia, 22042
Senay Ghidei, (703) 526-4382, Senay.Ghidei@Inova.org
- Recruiting
UTHealth/McGovern Medical School
Houston, Texas, 77030
Keyla Guevara, 713-500-6260, keyla.d.guevara@uth.tmc.edu
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Leah Gitajn, MD
- Recruiting
Vanderbilt University
Nashville, Tennessee, 37232
Karen Trochez, (615) 936-0347, karen.m.trochez@vumc.org
About this study
Official title: Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures: A Multicenter Randomized Controlled Trial
This is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision >3cm. Eligible participants will be randomized to receive either incisional negative pressure wound therapy (NPWT) or a non-suction standard-of-care wound dressing for their definitive wound management. The primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization.
- Being tested
- Incisional Negative Pressure Wound Therapy (NPWT)
- Medical subject headings
- Tibial Fractures, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incisional Negative Pressure Wound Therapy (NPWT)Device
Participants in the treatment group will be standardized and will receive incisional NPWT using the any incisional VAC system that can apply 75-125mmHg continuous suction to the incision. The VAC sponge will be placed over the surgical wound at least 2cm in width and >3cm in length.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Wound Care | No intervention | Patients randomized to the control group will receive standard wound care. |
| Incisional Negative Pressure Wound Therapy (NPWT) | Experimental | Patients randomized to the treatment group will receive wound care which includes the application of an incisional negative pressure wound vacuum. Receives: Device: Incisional Negative Pressure Wound Therapy (NPWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication composite outcome
The primary outcome will be a composite outcome. We will hierarchically assess the components of the composite outcome in the following order: (1) all-cause mortality, (2) injury-related amputation of the lower extremity, (3) number of surgeries to treat a deep or organ space infection (CDC criteria), (4) wound healing complications requiring reoperation, (5) nonoperative wound necrosis at 2 or 6 weeks, wound dehiscence at 2 or 6 weeks or superficial infection (CDC criteria), (6) SCAR-Q Symptom Scale, (7) SCAR-Q Appearance Scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Jan 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of TibiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization into study treatment arms (incisional NPWT or non-suction standard of care) will occur in variable permuted blocks, stratified by clinical center, in a 1:1 ratio. Patients will be randomized electronically by an online Data Management System maintained by the Coordinating Center at Johns Hopkins School of Public Health.
- Masking
- None (open label)
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- I. Leah Gitajn, MD, Principal investigator, Dartmouth-Hitchcock Medical CenterRenan Castillor, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337292
- Sponsor's protocol ID
- IRB00440042
- Acronym
- iVAC
- Status last verified
- May 2026
- First submitted
- 22 Mar 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06337292
- Acronym / sponsor ID
- iVAC / IRB00440042
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Mar 2024 (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.
This is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision >3cm. Eligible participants will be randomized to receive either incisional negative pressure wound therapy (NPWT) or a non-suction standard-of-care wound dressing for their definitive wound management. The primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization into study treatment arms (incisional NPWT or non-suction standard of care) will occur in variable permuted blocks, stratified by clinical center, in a 1:1 ratio. Patients will be randomized electronically by an online Data Management System maintained by the Coordinating Center at Johns Hopkins School of Public Health.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Wound Care | No intervention | –Patients randomized to the control group will receive standard wound care. |
| Incisional Negative Pressure Wound Therapy (NPWT) | Experimental | Device: Incisional Negative Pressure Wound Therapy (NPWT)Patients randomized to the treatment group will receive wound care which includes the application of an incisional negative pressure wound vacuum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All open or closed tibial plateau or pilon fractures treated operatively with internal fixation at high risk for complication. Any open Gustilo Type I, II or IIIA tibial shaft fracture treated definitively with internal or external fixation with or without ipsilateral leg compartment syndrome if at least one wound is primarily closed.
- We define high-risk fractures as those that are either:
- Requiring incision for fixation or debridement of 3 cm or greater.
- Patients 18 years of age or older
Key exclusion criteria (5 listed)
- The study injury is already infected at time of study enrollment.
- Patient is unable to receive incisional NPWT for any reason.
- Patients who have already had definitive fixation prior to enrollment in the study.
- Severe problems with maintaining follow-up (e.g., patients who are homeless at the time of injury or those who are intellectually challenged without adequate family support or who are prisoners).
- The study injury is a Gustilo Type IIIB or IIIC open fracture.
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 |
|---|---|---|
| Incisional Negative Pressure Wound Therapy (NPWT)Participants in the treatment group will be standardized and will receive incisional NPWT using the any incisional VAC system that can apply 75-125mmHg continuous suction to the incision. The VAC sponge will be placed over the surgical wound at least 2cm in width and >3cm in length. | Device | Incisional Negative Pressure Wound Therapy (NPWT) |
Primary outcome
Complication composite outcome
Time frame: 3 months
The primary outcome will be a composite outcome. We will hierarchically assess the components of the composite outcome in the following order: (1) all-cause mortality, (2) injury-related amputation of the lower extremity, (3) number of surgeries to treat a deep or organ space infection (CDC criteria), (4) wound healing complications requiring reoperation, (5) nonoperative wound necrosis at 2 or 6 weeks, wound dehiscence at 2 or 6 weeks or superficial infection (CDC criteria), (6) SCAR-Q Symptom Scale, (7) SCAR-Q Appearance Scale
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 12 May 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.
I. Leah Gitajn, MD principal investigator
Dartmouth-Hitchcock Medical Center
Renan Castillor, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
6 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 Incisional Negative Pressure Wound Therapy (NPWT) in people with Fracture of Tibia and Wound Heal, run by Major Extremity Trauma Research Consortium at 6 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 7 inclusion and 5 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 Leah Gitajn, MD (603-650-5133, ida.leah.gitajn@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication composite outcome (time frame: 3 months). 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 12 May 2026.