Acute Wounds From Trauma, Dehiscence or Surgical Complications
Conditions
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.
Interventions
DEVICEGauze suction (G-SUC)
Negative pressure wound therapy
DEVICEVacuum Assisted Closure Device (VAC)
Negative Pressure Wound Therapy
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change Per Day in Wound Surface Area | 7 days | 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 | 7 days | Wound volume was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Participants were followed for the duration of inpatient stay, an average of 5 days. | Time was measured from the start of the dressing change until the initiation of suction. |
| Pain Score With Dressing Changes | Participants were followed for the duration of inpatient stay, an average of 5 days. | 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 | Participants were followed for the duration of inpatient stay, an average of 5 days. | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 45 |
| 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 | 42 |
| Total | 87 |
Baseline characteristics
| Characteristic | G-SUC | Vacuum Assisted Closure | Total |
|---|---|---|---|
| Age, Continuous | 53 years | 54 years | 53 years |
| Region of Enrollment United States | 45 participants | 42 participants | 87 participants |
| Sex: Female, Male Female | 31 Participants | 23 Participants | 54 Participants |
| Sex: Female, Male Male | 14 Participants | 19 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 42 |
| serious Total, serious adverse events | 0 / 45 | 1 / 42 |
Outcome results
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.
Time frame: 7 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| G-SUC | Percent Change Per Day in Wound Surface Area | -4.5 % change per day |
| Vacuum Assisted Closure | Percent Change Per Day in Wound Surface Area | -4.9 % change per day |
p-value: 0.6Mixed Models Analysis
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.
Time frame: 7 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| G-SUC | Percent Change Per Day in Wound Volume | -8.4 % change per day |
| Vacuum Assisted Closure | Percent Change Per Day in Wound Volume | -9.8 % change per day |
p-value: 0.19Mixed Models Analysis
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).
Time frame: Participants were followed for the duration of inpatient stay, an average of 5 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| G-SUC | Average Cost of Supplies and Rental | 4.22 dollars | Standard Deviation 1.57 |
| Vacuum Assisted Closure | Average Cost of Supplies and Rental | 96.51 dollars | Standard Deviation 11.26 |
p-value: <0.01Wilcoxon (Mann-Whitney)
Secondary
Average Time Spent on Dressing Changes
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| G-SUC | Average Time Spent on Dressing Changes | 19 minutes | Standard Deviation 6 |
| Vacuum Assisted Closure | Average Time Spent on Dressing Changes | 31 minutes | Standard Deviation 13 |
p-value: <0.01Wilcoxon (Mann-Whitney)
Secondary
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| G-SUC | Failure to Maintain Dressing Because of Fluid or Suction Leaks | 0 participants |
| Vacuum Assisted Closure | Failure to Maintain Dressing Because of Fluid or Suction Leaks | 4 participants |
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.
Time frame: Participants were followed for the duration of inpatient stay, an average of 5 days.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| G-SUC | Pain Score With Dressing Changes | 0.50 units on a scale |
| Vacuum Assisted Closure | Pain Score With Dressing Changes | 1.73 units on a scale |
p-value: 0.02Mixed Models Analysis