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Recruiting Phase 3 Interventional

Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy

ClinicalTrials.gov ID: NCT05615844

Public ClinicalTrials.gov record NCT05615844. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 10:02 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Controlled Trial Comparing Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy for the Management of Severe Open Tibia Fracture Wounds

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05615844
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Enrollment
312 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 4, 2023
Primary completion
Mar 30, 2027
Completion
Sep 30, 2027
Last update posted
Aug 19, 2026

2023 – 2027

United States locations

U.S. sites
29
U.S. states
20
U.S. cities
27
Facility City State ZIP Site status
Dignity Health Chandler Regional Medical Center Chandler Arizona 85224 Recruiting
University of Arizona Tucson Arizona 85721 Recruiting
University of California, Davis Davis California 95616 Recruiting
University of Southern California Los Angeles California 90033 Recruiting
Cedars-Sinai Medical Center Los Angeles California 90048 Recruiting
University of California, Irvine Orange California 92868 Recruiting
Yale University New Haven Connecticut 06520 Recruiting
University of Florida Gainesville Florida 32611 Recruiting
University of Miami Miami Florida 33146 Recruiting
Indiana University Indianapolis Indiana 46202 Recruiting
University of Maryland, R Adams Cowley Shock Trauma Center Baltimore Maryland 21201 Recruiting
University of Maryland Capital Region Health Largo Maryland 20774 Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 Recruiting
University of Mississippi University Mississippi 38677 Recruiting
Bryan Medical Center Lincoln Nebraska 68506 Recruiting
University Medical Center of Southern Nevada Las Vegas Nevada 89102 Withdrawn
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03766 Recruiting
Sanford Medical Center Fargo North Dakota 58103 Recruiting
University of Cincinnati Cincinnati Ohio 45219 Recruiting
Bon Secours Mercy Health Cincinnati Ohio 45237 Recruiting
Slocum Center Eugene Oregon 97401 Recruiting
Ortegon Health & Science University Portland Oregon 97239 Recruiting
St. Luke's University Health Network Bethlehem Pennsylvania 18015 Recruiting
Prisma Health - Midlands Columbia South Carolina 29203 Recruiting
Prisma Health Greenville South Carolina 29605 Recruiting
Sanford Health Sioux Falls South Dakota 57104 Recruiting
University of Utah Salt Lake City Utah 84112 Recruiting
Inova Fairfax Falls Church Virginia 22042 Recruiting
University of Wisconsin Madison Wisconsin 53792 Withdrawn

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05615844, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 19, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05615844 live on ClinicalTrials.gov.

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