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Procellera and Negative Pressure Therapy for Acute Wounds

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ClinicalTrials.gov Identifier: NCT01938066
Recruitment Status : Completed
First Posted : September 10, 2013
Results First Posted : April 21, 2016
Last Update Posted : April 21, 2016
Sponsor:
Collaborator:
Vomaris Innovations
Information provided by (Responsible Party):
Gayle Gordillo, Ohio State University

Tracking Information
First Submitted Date  ICMJE September 4, 2013
First Posted Date  ICMJE September 10, 2013
Results First Submitted Date  ICMJE March 25, 2015
Results First Posted Date  ICMJE April 21, 2016
Last Update Posted Date April 21, 2016
Study Start Date  ICMJE July 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2016)
Wound Infection [ Time Frame: At the end of 5 days ]
At the end of 5 days all subjects will get a Culture and Sensitivity to see if they have an infection or what type of infection they have in the wound
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2013)
Wound Infection [ Time Frame: At the end of 5 days ]
At the end of 5 days all subjects will get a Culture and Sensitivity to see what type of infection they have in the wound
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2016)
Amount of Pain Medication Used (Morphine) [ Time Frame: 5 days ]
will measure the amount of pain medication used (morphine)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2013)
pain [ Time Frame: 5 days ]
will measure the amount of pain medication used
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Procellera and Negative Pressure Therapy for Acute Wounds
Official Title  ICMJE Clinical Outcomes for Patients With Acute Surgical Wounds Treated With Procellera and Negative Pressure Therapy Versus Standard of Care, Negative Pressure Therapy Only
Brief Summary The purpose of this study is to determine if Procellera speeds wound healing. The study will examine colonization (bacterial growth), pain and pain medication and reduced cost of care by using Procellera (an antimicrobial agent) under Negative Pressure Therapy placed on the wound after abdominal wall surgery. Procellera is a single layer dressing that helps to kill germs that cause infections. Negative Pressure Therapy is a vacuum device with a sponge that is placed in your wound to help heal the wound faster.
Detailed Description The study will consent 30 patients undergoing surgery through the abdominal wall and the skin incision will intentionally be left open. Subjects will be randomized using a random number generator. Each number will be placed in an envelope numbered 1-30. Arm 1 will be even numbers and Arm 2 will be odd numbers. A researcher not affiliated with the study will generate the numbers and place them in the envelopes. Arm 1 will place fifteen subjects on Negative Pressure Therapy Only and Arm 2 will place fifteen subjects on Negative Pressure and Procellera. Arm 1 (Negative Pressure Only) will have their dressing changed 3 times per week which is the standard of care for Negative Pressure Therapy. Arm 2 (Negative Pressure Therapy and Procellera) will have their dressing changed every 5 days. Arm 1 and 2 will have a tissue specimen taken on the 5th day only. The tissue will be taken from debrided material and sent for culture. The Negative Pressure Therapy Sponge, which is discarded after each dressing change, will be collected, lavaged with saline and the cells will be examined for macrophage function and the wound fluid will be tested for inflammation response. Photographs, wound measurements, pain scale and pain medication will also be completed at each dressing change. We will check the progress of the wound along with your surgeon during the subject's 30 day surgical follow up in the surgeon's office. The wound will be measured (if not healed), photograph's taken and their pain level assessed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Wound
Intervention  ICMJE
  • Device: Procellera
    bioelectric wound dressing
  • Device: negative pressure therapy
Study Arms  ICMJE
  • Active Comparator: Negative Pressure with Procellera
    Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.
    Interventions:
    • Device: Procellera
    • Device: negative pressure therapy
  • Sham Comparator: Negative Pressure Therapy only
    Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.
    Intervention: Device: negative pressure therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2013)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years old that are undergoing abdominal wall surgery

Exclusion Criteria:

  • Below 18 years old and not having abdominal wall surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01938066
Other Study ID Numbers  ICMJE 2013H0028
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gayle Gordillo, Ohio State University
Study Sponsor  ICMJE Gayle Gordillo
Collaborators  ICMJE Vomaris Innovations
Investigators  ICMJE
Principal Investigator: Gayle M Gordillo, MD Ohio State University
PRS Account Ohio State University
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP