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.
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
At a glance
Conditions
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.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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.