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

A Randomized Controlled Trial Comparing Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy for the Management of Severe Open Tibia Fracture Wounds

PHASE3 · University of Maryland, Baltimore · NCT05615844

This study tests whether using antibiotic cement bead pouches or negative pressure wound therapy helps people with severe open tibia fractures heal better and avoid complications after surgery.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment312 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of Maryland, Baltimore (other)
Locations34 sites (Chandler, Arizona and 33 other locations)
Trial IDNCT05615844 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with severe open tibia fractures requiring multiple irrigation and debridement procedures.

Not a fit: Patients who are not likely to achieve limb salvage or have medical contraindications to the treatments being tested may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could lead to improved management strategies for open tibia fractures, potentially reducing infection rates and complications.

How similar studies have performed: Emerging comparative studies suggest that the antibiotic bead pouch may significantly reduce infection risk compared to NPWT, indicating potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Chandler, Arizona and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Open tíbia Fracture

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.