Antibiotic Cement Bead Pouch vs. Negative Pressure Wound Therapy for Open Tibia Fractures

This study is comparing two ways to manage severe open tibia (shin bone) fractures that need several surgeries. You might be eligible if you are 18 or older, have a severe open tibia fracture, and need surgery within 72 hours. The study will randomly assign participants to receive either an Antibiotic Cement Bead Pouch (a mix of cement and antibiotics placed in the wound) or Negative Pressure Wound Therapy (NPWT), also known as a Wound VAC. Researchers want to see which method leads to better overall health outcomes, including avoiding amputation or further surgeries, six months after treatment. The study aims to enroll 312 participants, but its current status is unclear.

Study design
This is a multi-center randomized controlled trial planning to enroll 312 participants. Participants will be randomly assigned to one of two treatment groups.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Outcomes will be assessed at 6 weeks, 3 months, and 6 months post-surgery, with the primary outcome measured at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05615844

Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy

Recruiting
PHASE3Ages 18+InterventionalTreatment
University of Maryland, Baltimore
~312 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:Antibiotic Cement Bead PouchNegative Pressure Wound Therapy

At a glance

Recruiting sites
31 of 35 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical status
Measured over 6 months
Open tíbia Fracture

NCT05615844

Where you'd take part

This study runs at 35 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Beth Israel Deaconess Medical Center

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Bon Secours Mercy Health

    Cincinnati, Ohiostudy coordinator listed

    Recruiting

  • Bryan Medical Center

    Lincoln, Nebraskastudy coordinator listed

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • Dignity Health Chandler Regional Medical Center

    Chandler, Arizonastudy coordinator listed

    Recruiting

  • Indiana University

    Indianapolis, Indianastudy coordinator listed

    Recruiting

  • London Health Sciences Centre

    London, Ontario, Canadastudy coordinator listed

    Recruiting

  • Prisma Health - Midlands

    Columbia, South Carolinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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  • Clinical status6 months

    Clinical status is a hierarchal composite of the following outcomes: i) all-cause mortality ii) amputation at the fracture location iii) unplanned reoperation to manage wound complications, an infection, or promote fracture healing, iv) clinical fracture healing assessed using the Functional IndeX for Trauma (FIX-IT) instrument.