Completed

NCT Number: NCT00582179

Vacuum Assisted Closure as a Treatment for Draining Hematomas

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Draining Hematoma

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Alabama at Birmingham, Orthopaedic Trauma

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Pressure Dressing

Procedure

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.

VAC

Device

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.

Primary outcomes

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

Secondary outcomes

Prevent development of infection

Time frame: 5 - 10 days following surgery

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

KCI USA, Inc

Registry information

Official study title

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

Acronym: VAC-DH

Important dates

Study start: 2001
Primary completion: 2007
Study completion: 2007
First posted: Dec 28, 2007
Registry last updated: Oct 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.