Vacuum Assisted Closure as a Treatment for Draining Hematomas

Not Applicable

Completed

• Conditions: Draining Hematoma
• Interventions: Procedure: Standard Pressure Dressing; Device: VAC

• Registration Number: NCT00582179
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-27
• Study First Posted: 2007-12-28
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-28
• Last Update Posted: 2013-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1, A	Standard Pressure Dressing	Group A patients will be treated with a pressure dressing and observation.
2, B	VAC	Group B patients will be treated with a Vacuum Assisted Closure device (VAC).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Prevent development of infection	5 - 10 days following surgery

Trial Locations

Locations (1)

The University of Alabama at Birmingham, Orthopaedic Trauma; 🇺🇸 Birmingham, Alabama, United States