Clinical trial NCT01938066: 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
Overall status: COMPLETED
Phase: NA
Conditions: Wound
Keywords: procellera
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Vomaris Innovations
First posted: 2013-09-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Wound Infection
timeFrame: At the end of 5 days
Secondary outcomes:
measure: Amount of Pain Medication Used (Morphine)
timeFrame: 5 days
Other outcomes:
Locations:
city: Columbus
country: United States
facility: University Hosptial East
state: Ohio
Study officials:
affiliation: Ohio State University
name: Gayle M Gordillo, MD
role: PRINCIPAL_INVESTIGATOR
References: