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New treatment option for Fracture of Tibia
Official title Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures
ClinicalTrials.gov ID: NCT06337292
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All open or closed tibial plateau or pilon fractures treated operatively with internal fixation at high risk for complication. Any open Gustilo Type...
- 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...
- 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
You likely can't join if
- 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...
- The study injury is a Gustilo Type IIIB or IIIC open fracture.
See the full eligibility criteria
- 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Lebanon, New Hampshire, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Falls Church, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Lebanon, New Hampshire, United States; Nashville, Tennessee, United States; Houston, Texas, United States; Falls Church, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.