Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy

Part of paid clinical trials in Chandler, Arizona.

Sponsor: University of Maryland, Baltimore
Study ID: NCT05615844
Phase: PHASE3
Status: Recruiting

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Conditions

Open tíbia Fracture

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

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.
Negative Pressure Wound Therapy — DEVICE
Standard application of negative pressure wound therapy

Study Details

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.

Key Dates

Start date: Nov 5, 2023
Status verified: Feb 2026
Primary completion: Mar 31, 2027
Completion: Oct 1, 2027

Study Design

Enrollment: 312 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: 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.
Active Comparator: 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.

Primary Outcome Measure

Clinical status [ Time Frame: 6 months ]

Central Contacts

Heather Phipps, MPS
410-706-2492
[email protected]

Locations (29)

Facility	City	State	ZIP	Site coordinators
Dignity Health Chandler Regional Medical Center	Chandler	Arizona	85224	William Naylor, DO [email protected] (480) 728-4470
University of Arizona	Tucson	Arizona	85721	Michael McKee, MD [email protected] 602-827-2905
University of California, Davis	Davis	California	95616	Augustine Saiz, MD [email protected] 800-282-3284
Cedars-Sinai Medical Center	Los Angeles	California	90048	Carol Lin, MD [email protected] 310-423-9839
University of Southern California	Los Angeles	California	90033	Joseph Patterson, MD
University of California, Irvine	Orange	California	92868	Gerard Slobogean, MD [email protected] 714-456-1699
Yale University	New Haven	Connecticut	06520	Matthew Riedel, MD [email protected] 203-785-2579
University of Florida	Gainesville	Florida	32611	Jennifer Hagen, MD
University of Miami	Miami	Florida	33146	Marilyn Heng, MD
Indiana University	Indianapolis	Indiana	46202	Yohan Jang, MD
University of Maryland, R Adams Cowley Shock Trauma Center	Baltimore	Maryland	21201	Heather Phipps 410-706-2492 Mark Gage, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland Capital Region Health	Largo	Maryland	20774	Todd Jaeblon, MD
Beth Israel Deaconess Medical Center	Boston	Massachusetts	02215	John Wixted, MD [email protected] (617) 667-3940
University of Mississippi	University	Mississippi	38677	Patrick Bergin, MD
Bryan Medical Center	Lincoln	Nebraska	68506	Steven Shannon, MD
University Medical Center of Southern Nevada	Las Vegas	Nevada	89102	-
Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	03766	Ida L Gitajn, MD
Sanford Medical Center	Fargo	North Dakota	58103	Michael White, MD [email protected] (701) 234-2000
Bon Secours Mercy Health	Cincinnati	Ohio	45237	John Gentile, MD [email protected] 330-480-3990
University of Cincinnati	Cincinnati	Ohio	45219	Michael Beltran, MD
Slocum Center	Eugene	Oregon	97401	Brandon Wilkinson, MD [email protected] 541-485-8111
Ortegon Health & Science University	Portland	Oregon	97239	Zachary Working, MD
St. Luke's University Health Network	Bethlehem	Pennsylvania	18015	Douglas Lundy, MD [email protected] (484) 526-1735
Prisma Health - Midlands	Columbia	South Carolina	29203	Daniel Cunningham, MD [email protected] (803) 296-7846
Prisma Health	Greenville	South Carolina	29605	Kyle Jeray, MD
Sanford Health	Sioux Falls	South Dakota	57104	Robert Van Demark III, MD [email protected] 605-333-1000
University of Utah	Salt Lake City	Utah	84112	Lucas Marchand, MD
Inova Fairfax	Falls Church	Virginia	22042	Greg Gaski, MD
University of Wisconsin	Madison	Wisconsin	53792	-

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