Vacuum Assisted Closure as a Treatment for Draining Hematomas - Full Text View

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

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 ]

Estimated Enrollment:	100
Study Start Date:	September 2001
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1, A: Active Comparator 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.
2, B: Active Comparator 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.

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

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

Investigators


Principal Investigator:	James P Stannard, MD	The University of Alabama at Birmingham

More Information

Publications:

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.

Responsible Party:	The University of Alabama at Birmingham ( James P. Stannard, MD, Professor of Surgery, Assoc. Director of Orthopaedic Surgery )
Study ID Numbers:	F010316005, VAC2001-04
First Received:	December 19, 2007
Last Updated:	December 27, 2007
ClinicalTrials.gov Identifier:	NCT00582179
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

Study placed in the following topic categories:

Hematoma

Hemorrhage

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	University of Alabama at Birmingham
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00582179