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Vacuum Assisted Closure as a Treatment for Draining Hematomas

NCT00582179 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2013-10-01

No results posted yet for this study

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.

Conditions

  • Draining Hematoma

Interventions

PROCEDURE

Standard Pressure Dressing

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.

DEVICE

VAC

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.

Sponsors & Collaborators

  • KCI USA, Inc

    collaborator INDUSTRY

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • David A Volgas, MD · The University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00582179 on ClinicalTrials.gov