Comparison of Two Methods of Negative Pressure Wound Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00724750
First received: July 25, 2008
Last updated: September 24, 2015
Last verified: September 2015
Results First Received: July 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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

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


Participant Flow:   Overall Study
    G-SUC     Vacuum Assisted Closure  
STARTED     45     42  
COMPLETED     45     42  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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

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

Total Total of all reporting groups

Baseline Measures
    G-SUC     Vacuum Assisted Closure     Total  
Number of Participants  
[units: participants]
  45     42     87  
Age  
[units: years]
Mean (Full Range)
  53  
  (23 to 80)  
  54  
  (19 to 82)  
  53  
  (19 to 82)  
Gender  
[units: participants]
     
Female     31     23     54  
Male     14     19     33  
Region of Enrollment  
[units: participants]
     
United States     45     42     87  



  Outcome Measures
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1.  Primary:   Percent Change Per Day in Wound Surface Area   [ Time Frame: 7 days ]

2.  Primary:   Percent Change Per Day in Wound Volume   [ Time Frame: 7 days ]

3.  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. ]

4.  Secondary:   Average Time Spent on Dressing Changes   [ Time Frame: Participants were followed for the duration of inpatient stay, an average of 5 days. ]

5.  Secondary:   Pain Score With Dressing Changes   [ Time Frame: Participants were followed for the duration of inpatient stay, an average of 5 days. ]

6.  Secondary:   Average Cost of Supplies and Rental   [ Time Frame: Participants were followed for the duration of inpatient stay, an average of 5 days. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: lgottlie@surgery.bsd.uchicago.edu


Publications of Results:

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00724750     History of Changes
Other Study ID Numbers: 14817A
Study First Received: July 25, 2008
Results First Received: July 27, 2015
Last Updated: September 24, 2015
Health Authority: United States: Institutional Review Board