Actively Recruiting
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Led by University of Maryland, Baltimore · Updated on 2026-05-05
312
Participants Needed
34
Research Sites
203 weeks
Total Duration
On this page
Sponsors
U
University of Maryland, Baltimore
Lead Sponsor
M
McMaster University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Severe open tibia fracture requiring more than one irrigation and debridement procedure
- Planned internal or external fixation for fracture management
- Formal surgical debridement within 72 hours of injury
- All planned fracture surgeries performed by a participating surgeon or delegate
- Informed consent obtained
You will not qualify if you...
- Limb salvage unlikely to be successful beyond 6 months based on initial assessment
- Allergy or sensitivity to vancomycin or tobramycin antibiotics
- Medical or injury contraindication to negative pressure wound therapy (NPWT), such as vascular graft or exposed neurovascular structures
- Previous surgical debridement or fracture management at a non-participating hospital
- Chronic or acute infection at or near the fracture site at initial surgery
- Incarceration
- Women who are pregnant or planning pregnancy within 6 months
- Currently enrolled in a conflicting clinical study
- Unable to provide informed consent due to language barriers
- Anticipated difficulty with follow-up
- Prior enrollment in this trial
- Other exclusion reasons approved by the Methods Center
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 34 locations
1
Dignity Health Chandler Regional Medical Center
Chandler, Arizona, United States, 85224
Actively Recruiting
2
University of Arizona
Tucson, Arizona, United States, 85721
Actively Recruiting
3
University of California, Davis
Davis, California, United States, 95616
Actively Recruiting
4
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
5
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
6
University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
7
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
8
University of Florida
Gainesville, Florida, United States, 32611
Actively Recruiting
9
University of Miami
Miami, Florida, United States, 33146
Actively Recruiting
10
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
11
University of Maryland, R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
12
University of Maryland Capital Region Health
Largo, Maryland, United States, 20774
Actively Recruiting
13
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
14
University of Mississippi
University, Mississippi, United States, 38677
Actively Recruiting
15
Bryan Medical Center
Lincoln, Nebraska, United States, 68506
Actively Recruiting
16
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Withdrawn
17
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
Actively Recruiting
18
Sanford Medical Center
Fargo, North Dakota, United States, 58103
Actively Recruiting
19
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
20
Bon Secours Mercy Health
Cincinnati, Ohio, United States, 45237
Actively Recruiting
21
Slocum Center
Eugene, Oregon, United States, 97401
Actively Recruiting
22
Ortegon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
23
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States, 18015
Actively Recruiting
24
Prisma Health - Midlands
Columbia, South Carolina, United States, 29203
Actively Recruiting
25
Prisma Health
Greenville, South Carolina, United States, 29605
Actively Recruiting
26
Sanford Health
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
27
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
28
Inova Fairfax
Falls Church, Virginia, United States, 22042
Actively Recruiting
29
University of Wisconsin
Madison, Wisconsin, United States, 53792
Withdrawn
30
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Actively Recruiting
31
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
32
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
33
London Health Sciences Centre
London, Ontario, Canada, N6C 2R6
Actively Recruiting
34
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Actively Recruiting
Research Team
H
Heather Phipps, MPS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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