Clinical Trial: Vacuum Assisted Closure as a Treatment for Draining Hematomas

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Vacuum Assisted Closure as a Treatment For Draining Hematomas (Vacuum Assisted Closure in the Management of Traumatic Extremity Wounds)

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 Summary:

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.

Sponsor: University of Alabama at Birmingham

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Prevent development of infection [ Time Frame: 5 - 10 days following surgery ]

Original Secondary Outcome: Same as current

Information By: University of Alabama at Birmingham

Dates:
Date Received: December 19, 2007
Date Started: September 2001
Date Completion:
Last Updated: September 28, 2013
Last Verified: September 2013