CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
75 mmHg suction +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00829621
NCT00829621N/ACompleted
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Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)

University of Missouri-Columbia·interventional·Posted Jan 27, 2009·Updated Nov 7, 2016

In Brief

A clinical study evaluating 75 mmHg suction and 125 mmHg for Fractures, Closed. Completed, enrolled 20 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFractures, Closed
CountriesUnited States
CollaboratorsMedtronic

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 27, 2009
Enrollment StartDec 1, 2008
Primary CompletionMay 1, 2012
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 17.4 years ago

Interventions

75 mmHg suctionother

Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use.

125 mmHgother

Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.