Procellera and Negative Pressure Therapy for Acute Wounds
This trial is active, not recruiting.
|Treatments||procellera, negative pressure therapy|
|Start date||July 2013|
|End date||July 2015|
|Trial size||30 participants|
|Trial identifier||NCT01938066, 2013H0028|
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.
|Intervention model||parallel assignment|
time frame: At the end of 5 days
time frame: 5 days
Male or female participants from 18 years up to 69 years old.
Inclusion Criteria: - 18 years old that are undergoing abdominal wall surgery Exclusion Criteria: - Below 18 years old and not having abdominal wall surgery
|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|
|Principal investigator||Gayle M Gordillo, MD|
|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.|
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