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Procedure

Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)

N/A
Waitlist Available
Led By Brett D. Crist, MD
Research Sponsored by University of Missouri-Columbia
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 12-hours, 24-hours, 36-hours, and 48-hours after ivac application
Awards & highlights
No Placebo-Only Group

Summary

People who have been scheduled for surgery using Bone Morphogenic Protein (called BMP-2) and an incisional vacuum assisted closure device (called IVAC) will be asked to join this study. The purpose of this study is to see if using the IVAC device removes BMP-2 from the wound. BMP-2 is a protein used by the body to increase bone healing, decrease the need for additional surgery, and reduce infection rates. The IVAC is a device that involves a foam dressing secured with an adhesive drape to make an airtight seal over a surgical incision. Tubing runs from the foam dressing to a device that uses gentle suction to drain fluid out (like a vacuum). The IVAC stays on for 48-72 hours depending on amount of drainage. The IVAC by itself helps reduce wound swelling and complications (such as infection).

Eligible Conditions
  • Jones Fracture
  • Fractures

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-hours, 24-hours, 36-hours, and 48-hours after ivac application
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-hours, 24-hours, 36-hours, and 48-hours after ivac application for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Presence of BMP-2 in Effluent Collected in IVAC Canister

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 125 mmHg suctionExperimental Treatment1 Intervention
IVAC suction 125 mmHg
Group II: 75 mmHg suctionActive Control1 Intervention
IVAC suction 75 mmHg

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Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
381 Previous Clinical Trials
628,802 Total Patients Enrolled
MedtronicIndustry Sponsor
619 Previous Clinical Trials
764,068 Total Patients Enrolled
Brett D. Crist, MDPrincipal InvestigatorUniversity of Missouri-Columbia
1 Previous Clinical Trials
6 Total Patients Enrolled
~1 spots leftby Dec 2025
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