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Comparison of Two Methods of Negative Pressure Wound Therapy

This study has been completed.
Sponsor:
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00724750
First received: July 25, 2008
Last updated: February 13, 2009
Last verified: February 2009
History of Changes
  Purpose

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.

Condition Intervention
Acute Wounds From Trauma
Dehiscence or Surgical Complications
 Device: Gauze suction (G-SUC)
Device: Vacuum Assisted Closure Device (VAC)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Control Trial Comparing Two Methods of Negative Pressure Wound Therapy: Gauze Suction Versus Vacuum Assisted Closure Device

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Occurrence of positive wound culture during negative pressure therapy [ Time Frame: Measured at each dressing change. ] [ Designated as safety issue: Yes ]
  • Clearance of positive wound culture during negative pressure therapy [ Time Frame: Measured at each dressing change. ] [ Designated as safety issue: Yes ]
  • Wound Size [ Time Frame: Measured at each dressing change. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Failure to maintain dressing because of fluid or suction leaks [ Time Frame: Assessed daily during inpatient stay. ] [ Designated as safety issue: No ]
  • Time spent on dressing changes [ Time Frame: Measured during each dressing change. ] [ Designated as safety issue: No ]
  • Pain score with dressing changes [ Time Frame: Measured at each dressing change. ] [ Designated as safety issue: No ]
  • Cost of supplies and rental [ Time Frame: Measured with each dressing change. ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Gauze suction (G-SUC) Negative Pressure Wound Therapy
 Device: Gauze suction (G-SUC)
Negative pressure wound therapy
Active Comparator: 2
Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy
 Device: Vacuum Assisted Closure Device (VAC)
Negative Pressure Wound Therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Hospitalized patients at the University of Chicago Medical Center with acute wounds resulting from ether trauma, dehiscence or surgical complications

Exclusion Criteria:

  • Patients with systemic sepsis caused by wound infection
  • Those with grossly necrotic wounds
  • Malignancy in the wound
  • Wounds with untreated osteomyelitis
  • Patients with allergy to sulfamylon and Dakin's (sodium hypochlorite) Patients with 2 first criteria would become eligible once their sepsis resolves and/or necrotic tissue has been debrided from the wound.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00724750

Locations
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Lawrence J Gottlieb, MD University of Chicago
  More Information

No publications provided

Responsible Party: Lawrence Gottlieb, MD, University of Chicago Medical Center
ClinicalTrials.gov Identifier: NCT00724750     History of Changes
Other Study ID Numbers: 14817A
Study First Received: July 25, 2008
Last Updated: February 13, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 18, 2013