Draining Hematoma Clinical Trial
Official title:
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment