Procellera and Negative Pressure Therapy for Acute Wounds
Primary Purpose
Wound
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Procellera
negative pressure therapy
Sponsored by
About this trial
This is an interventional treatment trial for Wound focused on measuring procellera
Eligibility Criteria
Inclusion Criteria:
- 18 years old that are undergoing abdominal wall surgery
Exclusion Criteria:
- Below 18 years old and not having abdominal wall surgery
Sites / Locations
- University Hosptial East
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Negative Pressure with Procellera
Negative Pressure Therapy only
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Wound Infection
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
Amount of Pain Medication Used (Morphine)
will measure the amount of pain medication used (morphine)
Full Information
NCT ID
NCT01938066
First Posted
September 4, 2013
Last Updated
March 21, 2016
Sponsor
Gayle Gordillo
Collaborators
Vomaris Innovations
1. Study Identification
Unique Protocol Identification Number
NCT01938066
Brief Title
Procellera and Negative Pressure Therapy for Acute Wounds
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gayle Gordillo
Collaborators
Vomaris Innovations
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound
Keywords
procellera
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Negative Pressure with Procellera
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Negative Pressure Therapy only
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Procellera
Intervention Description
bioelectric wound dressing
Intervention Type
Device
Intervention Name(s)
negative pressure therapy
Primary Outcome Measure Information:
Title
Wound Infection
Description
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
Time Frame
At the end of 5 days
Secondary Outcome Measure Information:
Title
Amount of Pain Medication Used (Morphine)
Description
will measure the amount of pain medication used (morphine)
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years old that are undergoing abdominal wall surgery
Exclusion Criteria:
Below 18 years old and not having abdominal wall surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gayle M Gordillo, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hosptial East
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Procellera and Negative Pressure Therapy for Acute Wounds
We'll reach out to this number within 24 hrs