Clinical trial NCT00582179: Vacuum Assisted Closure as a Treatment for Draining Hematomas
Official title: Vacuum Assisted Closure as a Treatment For Draining Hematomas (Vacuum Assisted Closure in the Management of Traumatic Extremity Wounds)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Draining Hematoma
Keywords: Draining Hematoma
Vacuum Assisted Closure (VAC)
Negative Pressure Wound Therapy (NPWT)
Draining Hematoma following orthopaedic surgery
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: KCI USA, Inc
First posted: 2007-12-28
Enrollment: 94
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Dry and healed draining hematoma
timeFrame: If hematoma still draining 5 days post surgery, enter study; Still draining 10 days post surgery, return to OR for I&D
Secondary outcomes:
measure: Prevent development of infection
timeFrame: 5 - 10 days following surgery
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham, Orthopaedic Trauma
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: David A Volgas, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.