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

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.

Study Overview

• Status: Completed
• Conditions: Draining Hematoma
• Intervention / Treatment: Procedure: Standard Pressure Dressing; Device: VAC

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • The University of Alabama at Birmingham, Orthopaedic Trauma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Vacuum Assisted Closure device, Kinetics Concepts, Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Prevent development of infection	5 - 10 days following surgery

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: 3M
• Investigators: Principal Investigator: David A Volgas, MD, The University of Alabama at Birmingham

Publications and helpful links

General 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. doi: 10.7547/0970410.

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Primary Completion (Actual): March 1, 2007
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: December 19, 2007
• First Submitted That Met QC Criteria: December 27, 2007
• First Posted (Estimate): December 28, 2007

Study Record Updates

• Last Update Posted (Estimate): October 1, 2013
• Last Update Submitted That Met QC Criteria: September 28, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Draining Hematoma; Vacuum Assisted Closure (VAC); Negative Pressure Wound Therapy (NPWT); Draining Hematoma following orthopaedic surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Hematoma
• Other Study ID Numbers: F010316005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No