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Sponsored by: |
University of Alabama at Birmingham |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00582179 |
This project is designed as a prospective, randomized, comparative study evaluating the use of a negative pressure vacuum device in treating draining hematomas following traumatic injury.
Condition | Intervention |
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Draining Hematoma |
Procedure: Standard Pressure Dressing Device: VAC |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Vacuum Assisted Closure as a Treatment For Draining Hematomas (Vacuum Assisted Closure in the Management of Traumatic Extremity Wounds) |
Estimated Enrollment: | 100 |
Study Start Date: | September 2001 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1, A: Active Comparator
Group A patients will be treated with a pressure dressing and observation.
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Procedure: Standard Pressure Dressing
If hematoma still draining at 5 days post surgery, patients who randomize to Group A will have a standard pressure dressing applied and checked every 24-48 hours for continued draining. If still draining at 10 days post surgery, patient is at end point of study and must return to OR for Irrigation and Debridement of the wound. If infection occurs, patient is at end point of study and must return to OR for I&D.
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2, B: Active Comparator
Group B patients will be treated with a Vacuum Assisted Closure device (VAC).
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Device: VAC
If hematoma still draining at 5 days post surgery, patients who randomize to Group B will have a VAC negative pressure device applied and checked every 24-48 hours for continued draining. If still draining at 10 days post surgery, patient is at end point of study and must return to OR for Irrigation and Debridement of the wound. If infection occurs, patient is at end point of study and must return to OR for I&D.
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Application of the VAC device may significantly decrease the incidence of draining hematomas that require surgical irrigation and debridement. The aim of this project is to perform a prospective, randomized study evaluating the VAC negative pressure device as a treatment for draining hematomas. We will also analyze the cost of treating a hematoma with a VAC compared with currently employed treatments. Additionally, we will document the incidence of infection of the hematoma with and without use of the VAC device.
Patients who have a draining hematoma five days following surgery and who give informed consent to enter the study will be randomized into two groups.
Group A will be patients treated with a pressure dressing and observation, which is the most common current method of treatment. Group B will be patients treated with a VAC negative pressure device. Patients will be carefully monitored for continued drainage by evaluating the wounds and dressings clinically. Patients in either group that are still draining at ten days following surgery will be taken to the operating room for irrigation and debridement. Patients in either group who develop infection will be immediately treated with irrigation and debridement.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
The University of Alabama at Birmingham, Orthopaedic Trauma | |
Birmingham, Alabama, United States, 35294 |
Principal Investigator: | James P Stannard, MD | The University of Alabama at Birmingham |
Responsible Party: | The University of Alabama at Birmingham ( James P. Stannard, MD, Professor of Surgery, Assoc. Director of Orthopaedic Surgery ) |
Study ID Numbers: | F010316005, VAC2001-04 |
Study First Received: | December 19, 2007 |
Last Updated: | December 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00582179 History of Changes |
Health Authority: | United States: Institutional Review Board |
Draining Hematoma Vacuum Assisted Closure (VAC) Negative Pressure Wound Therapy (NPWT) Draining Hematoma following orthopaedic surgery |
Hematoma Hemorrhage |
Hematoma Pathologic Processes Hemorrhage |