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Anti-bacterial Agent
Antibiotic Beads vs Negative Pressure Therapy for Open Tibia Fracture (BeadsvsVac Trial)
Phase 3
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
BeadsvsVac Trial Summary
This trial will compare two wound healing treatments for people with severe open tibia fractures. Outcomes will be assessed at 6 weeks, 3 months, and 6 months after surgery. The primary outcome is a composite outcome to evaluate clinical status 6 months after randomization.
Who is the study for?
This trial is for adults over 18 with severe open tibia fractures needing multiple cleanings and debridement surgeries. They must plan to have internal or external fixation, receive initial surgery within 72 hours of injury, and all procedures done by a participating surgeon.Check my eligibility
What is being tested?
The study compares two treatments for managing temporary wounds in severe open tibia fractures: an antibiotic cement bead pouch versus negative pressure wound therapy (NPWT). Participants are randomly assigned to one of the treatments and followed up at several intervals post-surgery.See study design
What are the potential side effects?
Potential side effects may include irritation or allergic reactions from the antibiotic beads, complications like infection from either treatment method, discomfort associated with NPWT device use, and possible issues related to wound healing.
BeadsvsVac Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical status
Secondary outcome measures
Amputation
Clinical fracture healing
Mortality
+1 moreBeadsvsVac Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Antibiotic Cement Bead PouchExperimental Treatment1 Intervention
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.
Group II: Negative Pressure Wound Therapy (NPWT)Active Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,344 Total Patients Enrolled
1 Trials studying Open Tibia Fracture
356 Patients Enrolled for Open Tibia Fracture
McMaster UniversityOTHER
884 Previous Clinical Trials
2,598,004 Total Patients Enrolled
1 Trials studying Open Tibia Fracture
356 Patients Enrolled for Open Tibia Fracture
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants is this clinical trial recruiting?
"Affirmative. The clinicaltrials.gov database verifies that the recruitment process for this medical trial is currently underway, having first been published on November 5th of 2023 and recently edited on the 8th of the same month. A total of 312 potential participants are expected to be enrolled at a single site."
Answered by AI
Is there any risk associated with using Antibiotic Cement Bead Pouch in a medical context?
"Power's assessment of the safety profile of Antibiotic Cement Bead Pouch was a 3, based on the fact that it has reached Phase 3 trials and there is substantial evidence showing both efficacy and safety."
Answered by AI
Is it currently feasible for new participants to join this clinical experiment?
"Indeed, the latest information on clinicaltrials.gov illustrates that this study is still enrolling individuals. It was originally posted on November 5th 2023 and underwent its last update a few days later on 8th of the same month. This medical trial requires 312 participants from 1 clinic."
Answered by AI
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