Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Procellera and Negative Pressure Therapy for Acute Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Wound Device: Procellera Device: negative pressure therapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Outcomes for Patients With Acute Surgical Wounds Treated With Procellera and Negative Pressure Therapy Versus Standard of Care, Negative Pressure Therapy Only
Study Start Date : July 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: Procellera
bioelectric wound dressing

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.
Device: negative pressure therapy



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Amount of Pain Medication Used (Morphine) [ Time Frame: 5 days ]
    will measure the amount of pain medication used (morphine)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years old that are undergoing abdominal wall surgery

Exclusion Criteria:

  • Below 18 years old and not having abdominal wall surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938066


Locations
Layout table for location information
United States, Ohio
University Hosptial East
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Gayle Gordillo
Vomaris Innovations
Investigators
Layout table for investigator information
Principal Investigator: Gayle M Gordillo, MD Ohio State University

Layout table for additonal information
Responsible Party: Gayle Gordillo, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01938066     History of Changes
Other Study ID Numbers: 2013H0028
First Posted: September 10, 2013    Key Record Dates
Results First Posted: April 21, 2016
Last Update Posted: April 21, 2016
Last Verified: March 2016

Keywords provided by Gayle Gordillo, Ohio State University:
procellera

Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries