NCT06337292 Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures
| NCT ID | NCT06337292 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Major Extremity Trauma Research Consortium |
| Condition | Fracture of Tibia |
| Study Type | INTERVENTIONAL |
| Enrollment | 352 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 352 participants in total. It began in 2025-01-01 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. 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 3. Requiring incision for fixation or debridement of 3 cm or greater. 4. Patients 18 years of age or older Exclusion Criteria: 1. The study injury is already infected at time of study enrollment. 2. Patient is unable to receive incisional NPWT for any reason. 3. Patients who have already had definitive fixation prior to enrollment in the study. 4. 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). 5. The study injury is a Gustilo Type IIIB or IIIC open fracture.
Contact & Investigator
I. Leah Gitajn, MD
PRINCIPAL INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Frequently Asked Questions
Who can join the NCT06337292 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fracture of Tibia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06337292 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 352 participants.
Is NCT06337292 currently recruiting?
Yes, NCT06337292 is actively recruiting participants. Contact the research team at ida.leah.gitajn@hitchcock.org for enrollment information.
Where is the NCT06337292 trial being conducted?
This trial is being conducted at Baltimore, United States, Baltimore, United States, Lebanon, United States, Nashville, United States and 2 additional locations.
Who is sponsoring the NCT06337292 clinical trial?
NCT06337292 is sponsored by Major Extremity Trauma Research Consortium. The principal investigator is I. Leah Gitajn, MD at Dartmouth-Hitchcock Medical Center. The trial plans to enroll 352 participants.