Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy

NCT05615844 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: SSU00222774
• Study Type: interventional
• Target: 312
• Locations: 2 countries
• Sites: 34

Brief Summary

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. Outcomes will be assessed at 6 weeks, 3 months, and 6 months post-surgery. 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. This is a Phase III trial.

Conditions

Open tíbia Fracture

Outcome Measures

Primary Outcomes (1)

• Clinical status

  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.

  6 months

Secondary Outcomes (4)

• Mortality

  6 months

• Amputation

  6 months

• Unplanned reoperation(s)

  6 months

• Clinical fracture healing

  6 months

Study Arms (2)

Antibiotic Cement Bead Pouch

EXPERIMENTAL

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.

Drug: Antibiotic Cement Bead Pouch

Negative Pressure Wound Therapy (NPWT)

ACTIVE COMPARATOR

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.

Device: Negative Pressure Wound Therapy

Interventions

Antibiotic Cement Bead Pouch DRUG

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.

Antibiotic Cement Bead Pouch

Negative Pressure Wound Therapy DEVICE

Standard application of negative pressure wound therapy

Negative Pressure Wound Therapy (NPWT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• McMaster University: collaborator
• University of California, Irvine: collaborator
• University of Maryland, Baltimore: lead

Study Sites (34)

Dignity Health Chandler Regional Medical Center

Chandler, Arizona, 85224, United States

RECRUITING

University of Arizona

Tucson, Arizona, 85721, United States

RECRUITING

University of California, Davis

Davis, California, 95616, United States

RECRUITING

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

University of California, Irvine

Orange, California, 92868, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

University of Miami

Miami, Florida, 33146, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Maryland, R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

RECRUITING

University of Maryland Capital Region Health

Largo, Maryland, 20774, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

University of Mississippi

University, Mississippi, 38677, United States

RECRUITING

Bryan Medical Center

Lincoln, Nebraska, 68506, United States

RECRUITING

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

WITHDRAWN

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

RECRUITING

Sanford Medical Center

Fargo, North Dakota, 58103, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45219, United States

RECRUITING

Bon Secours Mercy Health

Cincinnati, Ohio, 45237, United States

RECRUITING

Slocum Center

Eugene, Oregon, 97401, United States

RECRUITING

Ortegon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

RECRUITING

Prisma Health - Midlands

Columbia, South Carolina, 29203, United States

RECRUITING

Prisma Health

Greenville, South Carolina, 29605, United States

RECRUITING

Sanford Health

Sioux Falls, South Dakota, 57104, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Inova Fairfax

Falls Church, Virginia, 22042, United States

RECRUITING

University of Wisconsin

Madison, Wisconsin, 53792, United States

WITHDRAWN

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

RECRUITING

University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, N6C 2R6, Canada

RECRUITING

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

RECRUITING

Related Publications (1)

• Marchand LS, Slobogean G, O'Hara NN, Harris AD, Grainger DW, Thabane L, Bhandari M, Della Rocca GJ, Kellam PJ, Zura RD, Marvel D, Wells JL, Gitajn IL, Jeray KJ, O'Toole RV, Working ZM, Natoli RM, Bergin PF, Hagen JE, Levack AE, Guerra-Farfan E, Schrank GM, Hebden JN, Mossuto F, Tsoutsounakis C, Pogorzelski D, Pineda H, Bzovsky S, Sprague S; BvV Investigators. Randomised controlled trial comparing antibiotic cement bead pouch versus negative pressure wound therapy for the management of severe open tibia fracture wounds: Beads versus VAC (BvV) protocol. BMJ Open. 2026 May 4;16(5):e088521. doi: 10.1136/bmjopen-2024-088521.

  PMID: 42082225 DERIVED

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Central Study Contacts

Heather Phipps, MPS

CONTACT

410-706-2492; hphipps@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Orthopaedics

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: November 14, 2022
• Study Start: November 5, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-02

Locations

CA (5); US (29)