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Compares treatment options for Open tíbia Fracture
Official title Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
ClinicalTrials.gov ID: NCT05615844
What this study is testing
What is Antibiotic Cement Bead Pouch?
Antibiotic Cement Bead Pouch is an investigational medicine, being studied as a potential treatment for open tíbia fracture.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The Beads vs Vac trial is a multi-centre randomized controlled trial of 312 participants with a severe open tibia fracture requiring multiple irrigation and debridement surgeries. Eligible participants will be randomized to receive either an antibiotic bead pouch or negative pressure wound therapy (NPWT) for their temporary open fracture wound management.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The are:
- Patients 18 years of age or older.
- Severe open tibia fracture requiring more than one irrigation and debridement procedure to treat the open fracture.
- Planned internal or external fixation for definitive fracture management.
- Formal surgical debridement within 72 hours of their injury.
You likely can't join if
- are:
- 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...
- Medical contraindication to antibiotic beads, including previously known allergies or sensitivities to vancomycin and/or tobramycin.
- Medical or injury contraindication to NPWT. Injury contraindications could include situations in which the NPWT could not be placed over a vascular...
- Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic (as applicable).
- Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
See the full eligibility criteria
- The are:
- Patients 18 years of age or older.
- Severe open tibia fracture requiring more than one irrigation and debridement procedure to treat the open fracture.
- Planned internal or external fixation for definitive fracture management.
- Formal surgical debridement within 72 hours of their injury.
- Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
- Informed consent obtained. The
- are:
- 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...
- Medical contraindication to antibiotic beads, including previously known allergies or sensitivities to vancomycin and/or tobramycin.
- 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.
- Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic (as applicable).
- Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
- Incarceration.
- Women of child-bearing potential who are pregnant or intending to become pregnant within the next 6 months.
- Currently enrolled in a study that does not permit co-enrollment.
- Unable to obtain informed consent due to language barriers.
- Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.
- Prior enrollment in the trial.
- Other reason to exclude the patient, as approved by the Methods Center.
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Tucson, Arizona, United States
- Davis, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- New Haven, Connecticut, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- Largo, Maryland, United States
- Boston, Massachusetts, United States
- University, Mississippi, United States
- Lincoln, Nebraska, United States
- Las Vegas, Nevada, United States
- Lebanon, New Hampshire, United States
- Fargo, North Dakota, United States
- Cincinnati, Ohio, United States
- Eugene, Oregon, United States
- Portland, Oregon, United States
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Tucson, Arizona, United States; Davis, California, United States; Los Angeles, California, United States; Orange, California, United States; New Haven, Connecticut, United States and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.