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

Primary Purpose

Draining Hematoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Pressure Dressing
VAC
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Draining Hematoma focused on measuring Draining Hematoma, Vacuum Assisted Closure (VAC), Negative Pressure Wound Therapy (NPWT), Draining Hematoma following orthopaedic surgery

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Alabama at Birmingham, Orthopaedic Trauma

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1, A

2, B

Arm Description

Group A patients will be treated with a pressure dressing and observation.

Group B patients will be treated with a Vacuum Assisted Closure device (VAC).

Outcomes

Primary Outcome Measures

Dry and healed draining hematoma

Secondary Outcome Measures

Prevent development of infection

Full Information

First Posted
December 19, 2007
Last Updated
September 28, 2013
Sponsor
University of Alabama at Birmingham
Collaborators
3M
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1. Study Identification

Unique Protocol Identification Number
NCT00582179
Brief Title
Vacuum Assisted Closure as a Treatment for Draining Hematomas
Acronym
VAC-DH
Official Title
Vacuum Assisted Closure as a Treatment For Draining Hematomas (Vacuum Assisted Closure in the Management of Traumatic Extremity Wounds)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
3M

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Draining Hematoma
Keywords
Draining Hematoma, Vacuum Assisted Closure (VAC), Negative Pressure Wound Therapy (NPWT), Draining Hematoma following orthopaedic surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1, A
Arm Type
Active Comparator
Arm Description
Group A patients will be treated with a pressure dressing and observation.
Arm Title
2, B
Arm Type
Active Comparator
Arm Description
Group B patients will be treated with a Vacuum Assisted Closure device (VAC).
Intervention Type
Procedure
Intervention Name(s)
Standard Pressure Dressing
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
VAC
Other Intervention Name(s)
Vacuum Assisted Closure device, Kinetics Concepts, Inc.
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Prevent development of infection
Time Frame
5 - 10 days following surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Volgas, MD
Organizational Affiliation
The University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Alabama at Birmingham, Orthopaedic Trauma
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17901348
Citation
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.
Results Reference
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Vacuum Assisted Closure as a Treatment for Draining Hematomas

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