Comparing antibiotic cement bead pouches to negative pressure wound therapy for open tibia fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial is a multi-centre randomized controlled trial involving 312 participants with severe open tibia fractures that require multiple surgeries for irrigation and debridement. Participants will be randomly assigned to receive either an antibiotic bead pouch or negative pressure wound therapy (NPWT) for managing their open fracture wounds. The primary outcome will assess clinical status six months after randomization, focusing on complications such as mortality, amputation, reoperation, and fracture healing. Secondary outcomes will evaluate each component of the primary outcome independently, providing a comprehensive analysis of the effectiveness of both treatment methods.

Why it matters

Who can join: the full rules

The inclusion criteria are:

1. Patients 18 years of age or older.
2. Severe open tibia fracture requiring more than one irrigation and debridement procedure to treat the open fracture.
3. Planned internal or external fixation for definitive fracture management.
4. Formal surgical debridement within 72 hours of their injury.
5. Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
6. Informed consent obtained.

The exclusion criteria are:

1. Due to the severity of injury, the treating surgeon does not believe limb salvage \>6 months is likely to be successful based on the emergency department or initial intraoperative assessment (prior to enrolment and randomization).
2. Medical contraindication to antibiotic beads, including previously known allergies or sensitivities to vancomycin and/or tobramycin.
3. Medical or injury contraindication to NPWT. Injury contraindications could include situations in which the NPWT could not be placed over a vascular graft or exposed neurovascular structure.
4. Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic (as applicable).
5. Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
6. Incarceration.
7. Women of child-bearing potential who are pregnant or intending to become pregnant within the next 6 months.
8. Currently enrolled in a study that does not permit co-enrollment.
9. Unable to obtain informed consent due to language barriers.
10. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.
11. Prior enrollment in the trial.
12. Other reason to exclude the patient, as approved by the Methods Center.

Where it's running

• Dignity Health Chandler Regional Medical Center
  Chandler, Arizona, United States Recruiting
• University of Arizona
  Tucson, Arizona, United States Recruiting
• University of California, Davis
  Davis, California, United States Recruiting
• University of Southern California
  Los Angeles, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• University of California, Irvine
  Orange, California, United States Recruiting

Study contacts

• Study coordinator: Heather Phipps, MPS
• Email: hphipps@som.umaryland.edu
• Phone: 410-706-2492

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.