Comparison of Two Methods of Negative Pressure Wound Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00724750
First received: July 25, 2008
Last updated: September 24, 2015
Last verified: September 2015
  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:
  • Percent Change Per Day in Wound Surface Area [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Wound surface area was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.

  • Percent Change Per Day in Wound Volume [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Wound volume was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.


Secondary Outcome Measures:
  • Failure to Maintain Dressing Because of Fluid or Suction Leaks [ Time Frame: Participants were followed for the duration of inpatient stay, an average of 5 days. ] [ Designated as safety issue: No ]
  • Average Time Spent on Dressing Changes [ Time Frame: Participants were followed for the duration of inpatient stay, an average of 5 days. ] [ Designated as safety issue: No ]
    Time was measured from the start of the dressing change until the initiation of suction.

  • Pain Score With Dressing Changes [ Time Frame: Participants were followed for the duration of inpatient stay, an average of 5 days. ] [ Designated as safety issue: No ]
    Self-reported pain levels were used to assess pain. Patients were asked to rate their pain level according to the 0 to 10 linear analog scale immediately before, during, and after removal of the dressing. The average number of dressing changes for the G-SUC group was 4.5 (range 2-15) and the average number of dressing changes for the VAC group was 2.8 (range 2-6). The sum of pain intensity differences (SPID) was used to facilitate comparison of pain levels. The SPID score was calculated for each dressing change using the formula: (pain during - pain before) + (pain after - pain during). Higher values indicating greater pain.

  • Average Cost of Supplies and Rental [ Time Frame: Participants were followed for the duration of inpatient stay, an average of 5 days. ] [ Designated as safety issue: No ]
    Direct costs for each type of dressing were measured. In the VAC group, this included rental charges for the equipment and the cost of supplies. In the G-SUC group, this included the cost of supplies (suction canisters, catheters or drains, tubing, gauze, and adhesive drapes).


Enrollment: 87
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: G-SUC
Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.
Device: Gauze suction (G-SUC)
Negative pressure wound therapy
Active Comparator: Vacuum Assisted Closure
Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00724750     History of Changes
Other Study ID Numbers: 14817A 
Study First Received: July 25, 2008
Results First Received: July 27, 2015
Last Updated: September 24, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 02, 2016