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Comparison of Two Methods of Negative Pressure Wound Therapy

Primary Purpose

Acute Wounds From Trauma, Dehiscence or Surgical Complications

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gauze suction (G-SUC)
Vacuum Assisted Closure Device (VAC)
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Wounds From Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Chicago Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

G-SUC

Vacuum Assisted Closure

Arm Description

Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.

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.

Outcomes

Primary Outcome Measures

Percent Change Per Day in Wound Surface Area
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
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
Average Time Spent on Dressing Changes
Time was measured from the start of the dressing change until the initiation of suction.
Pain Score With Dressing Changes
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
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).

Full Information

First Posted
July 25, 2008
Last Updated
September 24, 2015
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00724750
Brief Title
Comparison of Two Methods of Negative Pressure Wound Therapy
Official Title
Prospective Randomized Control Trial Comparing Two Methods of Negative Pressure Wound Therapy: Gauze Suction Versus Vacuum Assisted Closure Device
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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. 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. Compare the failure of each method of therapy by documenting the number of dressing that cannot be maintained because of fluid or suction. 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: G-SUC and VAC are equivalent for the treatment of uncomplicated wounds in the acute care, in-patient setting. G-SUC is more effective than VAC for management of infected wounds. G-SUC is more versatile than VAC, and functional G-SUC dressings can be maintained in situations where functional VAC dressings cannot. Negative pressure therapy with G-SUC is less costly than VAC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Wounds From Trauma, Dehiscence or Surgical Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G-SUC
Arm Type
Experimental
Arm Description
Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.
Arm Title
Vacuum Assisted Closure
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Gauze suction (G-SUC)
Intervention Description
Negative pressure wound therapy
Intervention Type
Device
Intervention Name(s)
Vacuum Assisted Closure Device (VAC)
Intervention Description
Negative Pressure Wound Therapy
Primary Outcome Measure Information:
Title
Percent Change Per Day in Wound Surface Area
Description
Wound surface area was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.
Time Frame
7 days
Title
Percent Change Per Day in Wound Volume
Description
Wound volume was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
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.
Title
Average Time Spent on Dressing Changes
Description
Time was measured from the start of the dressing change until the initiation of suction.
Time Frame
Participants were followed for the duration of inpatient stay, an average of 5 days.
Title
Pain Score With Dressing Changes
Description
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.
Time Frame
Participants were followed for the duration of inpatient stay, an average of 5 days.
Title
Average Cost of Supplies and Rental
Description
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).
Time Frame
Participants were followed for the duration of inpatient stay, an average of 5 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence J Gottlieb, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21712704
Citation
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.
Results Reference
result

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Comparison of Two Methods of Negative Pressure Wound Therapy

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