Vacuum Assisted Closure as a Treatment for Draining Hematomas
NCT ID: NCT00582179
Last Updated: 2013-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
94 participants
INTERVENTIONAL
2001-09-30
2007-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1, A
Group A patients will be treated with a pressure dressing and observation.
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.
2, B
Group B patients will be treated with a Vacuum Assisted Closure device (VAC).
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No clinical evidence of infection
* Adult patient (19 years and older)
Exclusion Criteria
* A surgical incision that can not be covered with VAC sponges and a water impermeable sheet (such Tegaderm) to achieve a closed vacuum environment over the wound
* Wounds associated with the surgical incision that are intentionally left open to heal with either a delayed primary closure or secondary granulation
* Abnormal coagulation leading to an expanding hematoma that will require surgical debridements
* Prisoners
* Pregnant Women
* Inability to comply with protocol
* Patients or family members who are unable or unwilling to sign study consent
19 Years
ALL
No
Sponsors
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KCI USA, Inc
INDUSTRY
University of Alabama at Birmingham
OTHER
Responsible Party
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Principal Investigators
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David A Volgas, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Alabama at Birmingham
Locations
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The University of Alabama at Birmingham, Orthopaedic Trauma
Birmingham, Alabama, United States
Countries
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References
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Ferdinando E, Guerin L, Jervis AO, Obidigbo H. Negative-pressure wound therapy and external fixation for infection and hematoma after hallux abducto valgus surgery. J Am Podiatr Med Assoc. 2007 Sep-Oct;97(5):410-4. doi: 10.7547/0970410.
Other Identifiers
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F010316005
Identifier Type: -
Identifier Source: org_study_id