Vacuum Assisted Closure as a Treatment for Draining Hematomas (VAC-DH)

This study has been completed.
Sponsor:
Collaborator:
KCI USA, Inc.
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00582179
First received: December 19, 2007
Last updated: September 28, 2013
Last verified: September 2013
  Purpose

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
Draining Hematoma
Procedure: Standard Pressure Dressing
Device: VAC

Study Type: Interventional
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)

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Prevent development of infection [ Time Frame: 5 - 10 days following surgery ] [ Designated as safety issue: No ]

Enrollment: 94
Study Start Date: September 2001
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582179

Locations
United States, Alabama
The University of Alabama at Birmingham, Orthopaedic Trauma
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
KCI USA, Inc.
Investigators
Principal Investigator: David A Volgas, MD The University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00582179     History of Changes
Other Study ID Numbers: F010316005
Study First Received: December 19, 2007
Last Updated: September 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Draining Hematoma
Vacuum Assisted Closure (VAC)
Negative Pressure Wound Therapy (NPWT)
Draining Hematoma following orthopaedic surgery

Additional relevant MeSH terms:
Hematoma
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014