Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
NCT ID: NCT05615844
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
312 participants
INTERVENTIONAL
2023-11-05
2027-10-01
Brief Summary
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Detailed Description
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The primary objective of this trial is to determine if the antibiotic bead pouch, compared to NPWT application, is more effective at reducing open tibia fracture complications. The primary outcome will be a composite outcome to evaluate clinical status six months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) injury-related amputation of the lower extremity, 3) unplanned reoperation to manage wound complications, infection, or delayed fracture healing, and 4) clinical fracture healing as assessed using the Functional IndeX for Trauma (FIX-IT) instrument. The secondary objectives will independently assess the four components of the primary outcome.
The trial population includes patients 18 years and older with a severe open tibia fracture requiring more than one irrigation and debridement and being treated with internal or external fixation for definitive fracture management. Patients who have contraindications to the NPWT or local intrawound antibiotics will be excluded.
312 participants will be randomized in a 1:1 ratio to receive either an intraoperative antibiotic bead pouch or negative pressure wound therapy (NPWT). Participants will receive their allocated wound management strategy at the conclusion of their first irrigation and debridement procedure. Participants will have follow-up assessments at 6 weeks, 3 months and 6 months post-fracture.
The primary outcome will be a composite outcome to evaluate clinical status six months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) injury-related amputation of the lower extremity, 3) unplanned reoperation to manage wound complications, infection, or delayed fracture healing, and 4) clinical fracture healing as assessed using the Functional IndeX for Trauma (FIX-IT) instrument. The secondary outcomes will independently assess the four components of the primary outcome. An Adjudication Committee will review all primary and secondary endpoints and a Data Safety Monitoring Committee (DSMC) will review all safety events.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Antibiotic Cement Bead Pouch
The antibiotic cement bead pouch involves placing temporary non-absorbable antibiotic-laden cement beads into the open fracture wound and sealing the wound with a large occlusive dressing for prophylaxis against bacteria.
The antibiotic beads used will be prepared intraoperatively by the surgical team. The bead recipe will be comprised of a ratio of 2 grams of vancomycin, 2.4 grams of tobramycin, and 40g (one bag) of PMMA cement. The beads will be handmade and approximately 10-mm in diameter. The number of beads placed in the wound will be at the discretion of the treating surgeon based on recipient wound size. As commonly practiced, the antibiotic beads may be exchanged for new beads at each subsequent irrigation and debridement surgery. The number of beads, the number of replaced beads, and the removal of the antibiotic beads will be recorded.
Antibiotic Cement Bead Pouch
The antibiotic bead pouch provides an antibiotic delivery mechanism. It is made by combining polymethyl methacrylate (PMMA) cement with generic forms of vancomycin and tobramycin powder.
Negative Pressure Wound Therapy (NPWT)
The NPWT system is a sealed dressing placed over the open fracture wound that includes an occlusive plastic wound dressing connected to a vacuum pump, tubing, and a canister to collect fluid. The pump creates a vacuum seal and exerts negative pressure on the wound to remove fluid and maintain a sealed environment. NPWT promotes wound healing through four primary mechanisms: 1) wound shrinkage or macrodeformation; 2) microdeformation at the foam-wound surface interface; 3) fluid removal; and 4) stabilization of the wound environment.
125 mmHg continuous negative pressure is the recommended NPWT device setting; however, the treating surgeon will be allowed to adjust these settings as clinically necessary.
The frequency and timing of NPWT changes will also be at the surgeon's discretion but is expected to primarily coincide with the timing of repeat debridement, typically every 24-72 hours until definitive management has occurred.
Negative Pressure Wound Therapy
Standard application of negative pressure wound therapy
Interventions
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Antibiotic Cement Bead Pouch
The antibiotic bead pouch provides an antibiotic delivery mechanism. It is made by combining polymethyl methacrylate (PMMA) cement with generic forms of vancomycin and tobramycin powder.
Negative Pressure Wound Therapy
Standard application of negative pressure wound therapy
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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McMaster University
OTHER
University of California, Irvine
OTHER
University of Maryland, Baltimore
OTHER
Responsible Party
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Mark Gage
Associate Professor, Department of Orthopaedics
Locations
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Dignity Health Chandler Regional Medical Center
Chandler, Arizona, United States
University of California, Davis
Davis, California, United States
University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Yale University
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
Indiana University
Indianapolis, Indiana, United States
University of Maryland, R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States
University of Maryland Capital Region Health
Largo, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Mississippi
University, Mississippi, United States
Bryan Medical Center
Lincoln, Nebraska, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Sanford Medical Center
Fargo, North Dakota, United States
University of Cincinnati
Cincinnati, Ohio, United States
Bon Secours Mercy Health
Cincinnati, Ohio, United States
Slocum Center
Eugene, Oregon, United States
Ortegon Health & Science University
Portland, Oregon, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
Prisma Health - Midlands
Columbia, South Carolina, United States
Prisma Health
Greenville, South Carolina, United States
Sanford Health
Sioux Falls, South Dakota, United States
University of Utah
Salt Lake City, Utah, United States
Inova Fairfax
Falls Church, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Royal Columbian Hospital
New Westminster, British Columbia, Canada
University of British Columbia
Vancouver, British Columbia, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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William Naylor, DO
Role: primary
Augustine Saiz, MD
Role: primary
Joseph Patterson, MD
Role: primary
Carol Lin, MD
Role: primary
Matthew Riedel, MD
Role: primary
Jennifer Hagen, MD
Role: primary
Marilyn Heng, MD
Role: primary
Yohan Jang, MD
Role: primary
Heather Phipps
Role: primary
Todd Jaeblon, MD
Role: primary
John Wixted, MD
Role: primary
Patrick Bergin, MD
Role: primary
Steven Shannon, MD
Role: primary
Erik Kubiak, MD
Role: primary
Ida L Gitajn, MD
Role: primary
Michael White, MD
Role: primary
Michael Beltran, MD
Role: primary
John Gentile, MD
Role: primary
Brandon Wilkinson, MD
Role: primary
Zachary Working, MD
Role: primary
Douglas Lundy, MD
Role: primary
Daniel Cunningham, MD
Role: primary
Kyle Jeray, MD
Role: primary
Robert Van Demark III, MD
Role: primary
Lucas Marchand, MD
Role: primary
Greg Gaski, MD
Role: primary
Christopher Domes, MD
Role: primary
Darius Viskontas, MD
Role: primary
David Stockton, MD
Role: primary
Jamal Al-Asiri, MD
Role: primary
Emil Schemitsch, MD
Role: primary
Steven Papp, MD
Role: primary
Other Identifiers
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SSU00222774
Identifier Type: -
Identifier Source: org_study_id