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NCT00829621 · ClinicalTrials.gov registry record · NA

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

A NA study of Fractures, Closed, sponsored by University of Missouri-Columbia.

Completed
Registry status
NA
Development phase
20
Enrollment target
1
Study location

NCT00829621: Completed NA study of Fractures, Closed, sponsored by University of Missouri-Columbia.

NCT00829621 is a NA study of Fractures, Closed that has completed, run by University of Missouri-Columbia. The registered enrollment target is 20 participants, below the 99-participant average among 3 other Fractures, Closed trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00829621, a NA study of Fractures, Closed, has completed, sponsored by University of Missouri-Columbia.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target
1
Study location

Study 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).

Primary Outcome

Presence of BMP-2 in effluent collected in IVAC canister

Conditions Studied

Interventions

  • OTHER 75 mmHg suction
  • OTHER 125 mmHg

Study Locations (1)

Missouri

  • University of Missouri - Columbia

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2008-12
Est. Completion 2013-12
Phase NA
University of Missouri-Columbia

291 total trials

What the finished NCT00829621 record still lists

NCT00829621 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 99-participant average among 3 other Fractures, Closed trials with a reported enrollment target (80% lower).

The record links to 1 condition, with Fractures, Closed appearing as the primary indexed condition, and to 2 interventions - of which 75 mmHg suction is the first listed.

NCT00829621 reports a single indexed study location in Missouri.

Frequently Asked Questions

What is clinical trial NCT00829621 about?

NCT00829621 is a clinical study titled "Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)". 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 use...

What is the current status of trial NCT00829621?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2008-12. Estimated completion is 2013-12.

What conditions does trial NCT00829621 study?

This clinical trial studies the following conditions: Fractures, Closed.

What interventions are being tested in trial NCT00829621?

The interventions under investigation include: 75 mmHg suction (OTHER), 125 mmHg (OTHER).

Who is sponsoring clinical trial NCT00829621?

This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00829621 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00829621, the US trial registry maintained by the National Library of Medicine. NCT00829621 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.