Wound
Conditions
Keywords
procellera
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.
Interventions
DEVICEProcellera
bioelectric wound dressing
Sponsors
Vomaris Innovations
Gayle Gordillo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* 18 years old that are undergoing abdominal wall surgery
Exclusion criteria
* Below 18 years old and not having abdominal wall surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Infection | 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
| Measure | Time frame | Description |
|---|---|---|
| Amount of Pain Medication Used (Morphine) | 5 days | will measure the amount of pain medication used (morphine) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Procellera: bioelectric wound dressing
negative pressure therapy | 14 |
| 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.
negative pressure therapy | 13 |
| Total | 27 |
Baseline characteristics
| Characteristic | Negative Pressure With Procellera | Negative Pressure Therapy Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 10 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 3 Participants | 14 Participants |
| Age, Continuous | 54.7 years STANDARD_DEVIATION 10 | 58.3 years STANDARD_DEVIATION 12 | 56.8 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 12 Participants | 20 Participants |
| Region of Enrollment United States | 14 participants | 13 participants | 27 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
| Weight | 215.5 lbs STANDARD_DEVIATION 66.2 | 202.1 lbs STANDARD_DEVIATION 85.1 | 210.6 lbs STANDARD_DEVIATION 74.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 |
Outcome results
Primary
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
Time frame: At the end of 5 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Negative Pressure With Procellera | Wound Infection | 13 participants |
| Negative Pressure Therapy Only | Wound Infection | 12 participants |
Secondary
Amount of Pain Medication Used (Morphine)
will measure the amount of pain medication used (morphine)
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Negative Pressure With Procellera | Amount of Pain Medication Used (Morphine) | 139.29 mg | Standard Deviation 116.05 |
| Negative Pressure Therapy Only | Amount of Pain Medication Used (Morphine) | 178.55 mg | Standard Deviation 147.28 |