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RECRUITING Phase 3

Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures

NCT06337292 · View on ClinicalTrials.gov ↗

Study 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. The secondary outcomes will independently assess the components of the primary outcome.

Interventions

  • DEVICE Incisional Negative Pressure Wound Therapy (NPWT)

Study Locations (2)

Maryland

  • University of Maryland R Adams Cowley Shock Trauma Center — Baltimore

New Hampshire

  • Dartmouth-Hitchcock Medical Center — Lebanon

Trial Details

FieldValue
Enrollment Target 352 participants
Start Date 2025-01-01
Est. Completion 2028-12-31
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06337292

The ClinicalTrials.gov registry entry for NCT06337292 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 352 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Major Extremity Trauma Research Consortium, which has 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Wound Heal appearing as the primary indexed condition, and to 1 intervention — of which Incisional Negative Pressure Wound Therapy (NPWT) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06337292 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Maryland, New Hampshire. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06337292 about?

NCT06337292 is a clinical study titled "Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures". 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 rece...

What is the current status of trial NCT06337292?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 352 participants. The study started on 2025-01-01. Estimated completion is 2028-12-31.

What conditions does trial NCT06337292 study?

This clinical trial studies the following conditions: Wound Heal, Fracture of Tibia, Infected Wound, Wound Complication, Wound Dehiscence. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06337292?

The interventions under investigation include: Incisional Negative Pressure Wound Therapy (NPWT) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06337292?

This trial is sponsored by Major Extremity Trauma Research Consortium, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06337292 being conducted?

This trial has 2 study locations across Maryland, New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial