Actively Recruiting
Led by University of Maryland, Baltimore · Updated on 2026-05-05
312
Participants Needed
34
Research Sites
26 weeks
Total Duration
U
University of Maryland, Baltimore
Lead Sponsor
M
McMaster University
Collaborating Sponsor
Researchers are evaluating wound management methods for adults with severe open tibia fractures requiring multiple irrigation and debridement surgeries. This Phase III trial compares an antibiotic cement bead pouch to negative pressure wound therapy (NPWT) to see which better reduces complications. The study addresses uncertainty about the best temporary wound care between surgeries and aims to fill gaps in knowledge about these two approaches. Participants will be randomly assigned to one of two groups. One group receives an antibiotic bead pouch where antibiotic-laden cement beads are placed in the wound and sealed with a dressing. Beads may be replaced during subsequent surgeries. The other group receives NPWT, a sealed dressing connected to a vacuum pump that removes fluid and promotes healing. NPWT settings and changes are managed by the surgeon, typically every 24-72 hours until final fracture treatment. Participants will be followed for six months with assessments at 6 weeks, 3 months, and 6 months after surgery. Researchers will evaluate a composite outcome including mortality, amputation, unplanned reoperations, and fracture healing using the Functional IndeX for Trauma (FIX-IT) tool. Safety events and outcomes will be reviewed by committees. The total study duration for each participant spans these follow-up periods to monitor healing and complications.
CONDITIONS
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until definitive fracture management is completed, typically several weeks
Participants receive either an antibiotic cement bead pouch placed into the open fracture wound or negative pressure wound therapy (NPWT) applied after their first irrigation and debridement surgery. The treatment involves managing the open fracture wound between multiple irrigation and debridement surgeries.
Multiple wound management visits, often coinciding with repeat irrigation and debridement surgeries every 24-72 hours
Duration - 6 months
Participants have follow-up assessments to evaluate wound healing, infection, and clinical fracture healing after treatment.
3 visits at 6 weeks, 3 months, and 6 months post-fracture
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
H
Heather Phipps, MPS
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lucas S Marchand, Gerard Slobogean, Nathan N O'Hara...
https://pubmed.ncbi.nlm.nih.gov/42082225