Comparison of Two Methods of Negative Pressure Wound Therapy

NCT ID: NCT00724750

Last Updated: 2015-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2008-05-31

Brief 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.

Conditions

Acute Wounds From Trauma; Dehiscence or Surgical Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Gauze suction (G-SUC)

Intervention Type: DEVICE

Negative pressure wound therapy

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.

Group Type: ACTIVE_COMPARATOR

Vacuum Assisted Closure Device (VAC)

Intervention Type: DEVICE

Negative Pressure Wound Therapy

Interventions

Gauze suction (G-SUC)

Negative pressure wound therapy

Intervention Type: DEVICE

Vacuum Assisted Closure Device (VAC)

Negative Pressure Wound Therapy

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lawrence J Gottlieb, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago Medical Center

Chicago, Illinois, United States

Countries

United States

References

Dorafshar AH, Franczyk M, Gottlieb LJ, Wroblewski KE, Lohman RF. A prospective randomized trial comparing subatmospheric wound therapy with a sealed gauze dressing and the standard vacuum-assisted closure device. Ann Plast Surg. 2012 Jul;69(1):79-84. doi: 10.1097/SAP.0b013e318221286c.

Reference Type: RESULT

PMID: 21712704 (View on PubMed)

Other Identifiers

14817A

Identifier Type: -

Identifier Source: org_study_id