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Comparison of Two Methods of Negative Pressure Wound Therapy

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ClinicalTrials.gov Identifier: NCT00724750
Recruitment Status : Completed
First Posted : July 30, 2008
Results First Posted : October 19, 2015
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Wounds From Trauma
Dehiscence or Surgical Complications
Interventions Device: Gauze suction (G-SUC)
Device: Vacuum Assisted Closure Device (VAC)
Enrollment 87
Recruitment Details  
Pre-assignment Details  
Arm/Group Title G-SUC Vacuum Assisted Closure
Hide Arm/Group 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.

Gauze suction (G-SUC): Negative pressure wound therapy

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

Period Title: Overall Study
Started 45 42
Completed 45 42
Not Completed 0 0
Arm/Group Title G-SUC Vacuum Assisted Closure Total
Hide Arm/Group 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.

Gauze suction (G-SUC): Negative pressure wound therapy

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

Total of all reporting groups
Overall Number of Baseline Participants 45 42 87
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants 42 participants 87 participants
53
(23 to 80)
54
(19 to 82)
53
(19 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 42 participants 87 participants
Female
31
  68.9%
23
  54.8%
54
  62.1%
Male
14
  31.1%
19
  45.2%
33
  37.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 42 participants 87 participants
45 42 87
1.Primary Outcome
Title Percent Change Per Day in Wound Surface Area
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title G-SUC Vacuum Assisted Closure
Hide Arm/Group 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.

Gauze suction (G-SUC): Negative pressure wound therapy

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

Overall Number of Participants Analyzed 45 42
Mean (95% Confidence Interval)
Unit of Measure: % change per day
-4.5
(-5.3 to -3.8)
-4.9
(-6.0 to -3.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection G-SUC, Vacuum Assisted Closure
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority margin was 5%/day. For 80% power and a significance (alpha) level of 0.05; and assuming a common standard deviation of 9%, 41 subjects per group were needed.
Statistical Test of Hypothesis P-Value 0.60
Comments The rate of change for the 2 groups was compared by testing the treatment-by-time interaction in the model.
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title Percent Change Per Day in Wound Volume
Hide Description Wound volume was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.
Time Frame 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title G-SUC Vacuum Assisted Closure
Hide Arm/Group 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.

Gauze suction (G-SUC): Negative pressure wound therapy

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

Overall Number of Participants Analyzed 45 42
Mean (95% Confidence Interval)
Unit of Measure: % change per day
-8.4
(-9.5 to -7.2)
-9.8
(-11.5 to -8.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection G-SUC, Vacuum Assisted Closure
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority margin was 5%/day.
Statistical Test of Hypothesis P-Value 0.19
Comments The rate of change for the 2 groups was compared by testing the treatment-by-time interaction.
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Failure to Maintain Dressing Because of Fluid or Suction Leaks
Hide Description [Not Specified]
Time Frame Participants were followed for the duration of inpatient stay, an average of 5 days.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title G-SUC Vacuum Assisted Closure
Hide Arm/Group 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.

Gauze suction (G-SUC): Negative pressure wound therapy

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

Overall Number of Participants Analyzed 45 42
Measure Type: Number
Unit of Measure: participants
0 4
4.Secondary Outcome
Title Average Time Spent on Dressing Changes
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title G-SUC Vacuum Assisted Closure
Hide Arm/Group 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.

Gauze suction (G-SUC): Negative pressure wound therapy

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

Overall Number of Participants Analyzed 45 42
Mean (Standard Deviation)
Unit of Measure: minutes
19  (6) 31  (13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection G-SUC, Vacuum Assisted Closure
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Pain Score With Dressing Changes
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title G-SUC Vacuum Assisted Closure
Hide Arm/Group 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.

Gauze suction (G-SUC): Negative pressure wound therapy

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

Overall Number of Participants Analyzed 45 42
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.50
(-0.11 to 1.11)
1.73
(0.91 to 2.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection G-SUC, Vacuum Assisted Closure
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
6.Secondary Outcome
Title Average Cost of Supplies and Rental
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title G-SUC Vacuum Assisted Closure
Hide Arm/Group 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.

Gauze suction (G-SUC): Negative pressure wound therapy

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

Overall Number of Participants Analyzed 45 42
Mean (Standard Deviation)
Unit of Measure: dollars
4.22  (1.57) 96.51  (11.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection G-SUC, Vacuum Assisted Closure
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title G-SUC Vacuum Assisted Closure
Hide Arm/Group 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.

Gauze suction (G-SUC): Negative pressure wound therapy

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

All-Cause Mortality
G-SUC Vacuum Assisted Closure
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
G-SUC Vacuum Assisted Closure
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   1/42 (2.38%) 
Vascular disorders     
Hematoma *  0/45 (0.00%)  1/42 (2.38%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
G-SUC Vacuum Assisted Closure
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/42 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Lawrence Gottlieb
Organization: University of Chicago
Phone: (773) 702-6302
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00724750     History of Changes
Other Study ID Numbers: 14817A
First Submitted: July 25, 2008
First Posted: July 30, 2008
Results First Submitted: July 27, 2015
Results First Posted: October 19, 2015
Last Update Posted: October 19, 2015