Vacuum Assisted Closure as a Treatment for Draining Hematomas (VAC-DH)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vacuum Assisted Closure as a Treatment For Draining Hematomas (Vacuum Assisted Closure in the Management of Traumatic Extremity Wounds)|
- 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 ] [ Designated as safety issue: No ]
- Prevent development of infection [ Time Frame: 5 - 10 days following surgery ] [ Designated as safety issue: No ]
|Study Start Date:||September 2001|
|Study Completion Date:||March 2007|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|