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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:
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:
Our hypotheses are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-SUC | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gauze suction (G-SUC) | Device | Negative pressure wound therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days |
| 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. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Failure to Maintain Dressing Because of Fluid or Suction Leaks | Participants were followed for the duration of inpatient stay, an average of 5 days. | |
| Average Time Spent on Dressing Changes | Time was measured from the start of the dressing change until the initiation of suction. |
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Inclusion Criteria:
- Hospitalized patients at the University of Chicago Medical Center with acute wounds resulting from ether trauma, dehiscence or surgical complications
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence J Gottlieb, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21712704 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Gauze suction (G-SUC): Negative pressure wound therapy |
| FG001 | 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. Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Gauze suction (G-SUC): Negative pressure wound therapy |
| BG001 | Vacuum Assisted Closure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | % change per day | 7 days |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Gauze suction (G-SUC): Negative pressure wound therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lawrence Gottlieb | University of Chicago | (773) 702-6302 | lgottlie@surgery.bsd.uchicago.edu |
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| Vacuum Assisted Closure Device (VAC) |
| Device |
Negative Pressure Wound Therapy |
|
| Participants were followed for the duration of inpatient stay, an average of 5 days. |
| 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. | Participants were followed for the duration of inpatient stay, an average of 5 days. |
| 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). | Participants were followed for the duration of inpatient stay, an average of 5 days. |
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. Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | % change per day | 7 days |
|
|
|
|
| Secondary | Failure to Maintain Dressing Because of Fluid or Suction Leaks | Posted | Number | participants | Participants were followed for the duration of inpatient stay, an average of 5 days. |
|
|
|
| Secondary | Average Time Spent on Dressing Changes | Time was measured from the start of the dressing change until the initiation of suction. | Posted | Mean | Standard Deviation | minutes | Participants were followed for the duration of inpatient stay, an average of 5 days. |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Participants were followed for the duration of inpatient stay, an average of 5 days. |
|
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | dollars | Participants were followed for the duration of inpatient stay, an average of 5 days. |
|
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | 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. Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy | 1 | 42 | 0 | 42 |
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