Vacuum Assisted Closure as a Treatment for Draining Hematomas (VAC-DH)
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|ClinicalTrials.gov Identifier: NCT00582179|
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : October 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Draining Hematoma||Procedure: Standard Pressure Dressing Device: VAC||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vacuum Assisted Closure as a Treatment For Draining Hematomas (Vacuum Assisted Closure in the Management of Traumatic Extremity Wounds)|
|Study Start Date :||September 2001|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||March 2007|
Active Comparator: 1, A
Group A patients will be treated with a pressure dressing and observation.
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.
Active Comparator: 2, B
Group B patients will be treated with a Vacuum Assisted Closure 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.
Other Name: Vacuum Assisted Closure device, Kinetics Concepts, Inc.
- Dry and healed draining hematoma [ Time Frame: If hematoma still draining 5 days post surgery, enter study; Still draining 10 days post surgery, return to OR for I&D ]
- Prevent development of infection [ Time Frame: 5 - 10 days following surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582179
|United States, Alabama|
|The University of Alabama at Birmingham, Orthopaedic Trauma|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||David A Volgas, MD||The University of Alabama at Birmingham|