CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 87 enrolled
Drug / intervention
Gauze suction (G-SUC) +1 moredevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00724750
NCT00724750N/ACompleted

Prospective Randomized Control Trial Comparing Two Methods of Negative Pressure Wound Therapy: Gauze Suction Versus Vacuum Assisted Closure Device

University of Chicago·interventional·Posted Jul 30, 2008·Updated Oct 19, 2015

In Brief

A clinical study evaluating Gauze suction (G-SUC) and Vacuum Assisted Closure Device (VAC) for Acute Wounds From Trauma and Dehiscence or Surgical Complications. Completed, enrolled 87 participants across 1 site.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 30, 2008
Enrollment StartJul 1, 2006
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.9 years ago

Interventions

Gauze suction (G-SUC)device

Negative pressure wound therapy

Vacuum Assisted Closure Device (VAC)device

Negative Pressure Wound Therapy