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Vacuum Assisted Closure as a Treatment for Draining Hematomas (VAC-DH)
This study has been suspended.
( Sponsor's request while statistical analysis is being conducted. )
Study NCT00582179   Information provided by University of Alabama at Birmingham
First Received: December 19, 2007   Last Updated: December 27, 2007   History of Changes

December 19, 2007
December 27, 2007
September 2001
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00582179 on ClinicalTrials.gov Archive Site
Prevent development of infection [ Time Frame: 5 - 10 days following surgery ] [ Designated as safety issue: No ]
Same as current
 
Vacuum Assisted Closure as a Treatment for Draining Hematomas
Vacuum Assisted Closure as a Treatment For Draining Hematomas (Vacuum Assisted Closure in the Management of Traumatic Extremity Wounds)

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.

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.

 
Interventional
Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Draining Hematoma
  • Procedure: Standard Pressure Dressing
  • Device: VAC
  • Active Comparator: Group A patients will be treated with a pressure dressing and observation.
  • Active Comparator: Group B patients will be treated with a Vacuum Assisted Closure device (VAC).
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Suspended
100
December 2008
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient who has had an orthopaedic surgical procedure following trauma and has a draining wound for at least five days
  • No clinical evidence of infection
  • Adult patient (19 years and older)

Exclusion Criteria:

  • An infected hematoma. Infection will be defined by clinical signs and symptoms of infection that include increasing drainage, increasing pain, purulent drainage, and increasing erythema. Any hematomas that are thought to be infected will be cultured to confirm the diagnosis
  • 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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00582179
James P. Stannard, MD, Professor of Surgery, Assoc. Director of Orthopaedic Surgery, The University of Alabama at Birmingham
F010316005, VAC2001-04
University of Alabama at Birmingham
 
Principal Investigator: James P Stannard, MD The University of Alabama at Birmingham
University of Alabama at Birmingham
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP