Comparison of Two Methods of Negative Pressure Wound Therapy
Summary
The current standard for negative pressure wound therapy is the Vacuum Assisted Closure Device (VAC), a commercial system that utilizes a computerized suction pump to apply negative pressure to an open-cell poly-urethane foam dressing sealed over a wound. The VAC system is effective but has some drawbacks:
- The system is expensive.
- There us conflicting data about the effectiveness of VAC therapy for infected wounds.
- VAC therapy is difficult to use (and frequently fails) in wounds with excess fluid drainage, and in wounds near body orifices.
Over the past 4 years, we have accumulated additional experience with negative pressure wound therapy using wall suction applied to sealed gauze dressings with about 30 patients. We call this method G-SUC and have used it when we have been unable to maintain a dressing seal with the VAC system (due to excess drainage or wound location), for management if infected wounds. We have found this method to be effective without any specific negative side effects.
Our specific aims are:
1. Compare the effectiveness of G-SUC and standard VAC therapy. Outcomes measured for each method will include the proportional change in wound size over 1 - 2 weeks.
2. Compare the effectiveness of G-SUC and VAC system in controlling wound infections as measured by the number of patients who are able to clear infection by 4 days.
3. Compare the failure of each method of therapy by documenting the number of dressing that cannot be maintained because of fluid or suction.
4. Measure and compare the cost of wound treatment with the two methods including direct cost and time spent at the bed side performing the dressing change.
Our hypotheses are:
1. G-SUC and VAC are equivalent for the treatment of uncomplicated wounds in the acute care, in-patient setting.
2. G-SUC is more effective than VAC for management of infected wounds.
3. G-SUC is more versatile than VAC, and functional G-SUC dressings can be maintained in situations where functional VAC dressings cannot.
4. Negative pressure therapy with G-SUC is less costly than VAC.
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Acute Wounds From Trauma
Intervention
Gauze suction (G-SUC), Vacuum Assisted Closure Device (VAC)
Location
University of Chicago Medical Center
Chicago
Illinois
United States
60637
Status
Completed
Source
University of Chicago
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00724750
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Occlusive Dressings
Material, usually gauze or absorbent cotton, used to cover and protect wounds, to seal them from contact with air or bacteria. (From Dorland, 27th ed)
Suction
The removal of secretions, gas or fluid from hollow or tubular organs or cavities by means of a tube and a device that acts on negative pressure.
Vacuum Extraction, Obstetrical
Removal of the fetus from the uterus or vagina at or near the end of pregnancy with a metal traction cup that is attached to the fetus' head. Negative pressure is applied and traction is made on a chain passed through the suction tube. (From Stedman, 26th ed & Dorland, 28th ed)
Head Injuries, Penetrating
Head injuries which feature compromise of the skull and dura mater. These may result from gunshot wounds (WOUNDS, GUNSHOT), stab wounds (WOUNDS, STAB), and other forms of trauma.
Vacuum Curettage
Aspiration of the contents of the uterus with a vacuum curette.
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