NCT00582179

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 28, 2007

Completed
Last Updated

October 1, 2013

Status Verified

September 1, 2013

Enrollment Period

5.5 years

First QC Date

December 19, 2007

Last Update Submit

September 28, 2013

Conditions

Draining Hematoma

Keywords

Draining HematomaVacuum Assisted Closure (VAC)Negative Pressure Wound Therapy (NPWT)Draining Hematoma following orthopaedic surgery

Outcome Measures

Primary Outcomes (1)

  • Dry and healed draining hematoma

    If hematoma still draining 5 days post surgery, enter study; Still draining 10 days post surgery, return to OR for I&D

Secondary Outcomes (1)

  • Prevent development of infection

    5 - 10 days following surgery

Study Arms (2)

1, A

ACTIVE COMPARATOR

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

Procedure: Standard Pressure Dressing

2, B

ACTIVE COMPARATOR

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

Device: VAC

Interventions

Standard Pressure DressingPROCEDURE

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.

1, A
VACDEVICE

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.

Also known as: Vacuum Assisted Closure device, Kinetics Concepts, Inc.
2, B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Alabama at Birmingham, Orthopaedic Trauma

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • 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.

    PMID: 17901348BACKGROUND

Study Officials

  • David A Volgas, MD

    The University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 28, 2007

Study Start

September 1, 2001

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

October 1, 2013

Record last verified: 2013-09

Locations

US(1)