An interventional study of Procellera and negative pressure therapy in Wound, sponsored by Gayle Gordillo. Completed at 1 site in United States. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2016-04-21.
Sponsored by Gayle Gordillo · Not applicable, Interventional, and Treatment
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.
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 30 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Gayle Gordillo is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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 · Device: negative pressure therapy
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
bioelectric wound dressing
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
Amount of Pain Medication Used (Morphine)
will measure the amount of pain medication used (morphine)
Time frame: 5 days
| Milestone | Negative Pressure With Procellera | Negative Pressure Therapy Only |
|---|---|---|
| Started | 15 | 15 |
| Completed | 14 | 13 |
| Not completed | 1 | 2 |
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
| participants | Negative Pressure With Procellera | Negative Pressure Therapy Only |
|---|---|---|
| Wound Infection | 13 | 12 |
will measure the amount of pain medication used (morphine)
| mg | Negative Pressure With Procellera | Negative Pressure Therapy Only |
|---|---|---|
| Amount of Pain Medication Used (Morphine) | 139.29 ± 116.05 | 178.55 ± 147.28 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Negative Pressure With Procellera | — | 0/14 (0%) | 0/14 (0%) |
| Negative Pressure Therapy Only | — | 0/13 (0%) | 0/13 (0%) |
| Age, Categorical(Participants) | Negative Pressure With Procellera | Negative Pressure Therapy Only | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 3 | 14 |
| >=65 years | 3 | 10 | 13 |
| Age, Continuous(years) | Negative Pressure With Procellera | Negative Pressure Therapy Only | Total |
|---|---|---|---|
| Mean | 54.7 ± 10 | 58.3 ± 12 | 56.8 ± 11 |
| Sex: Female, Male(Participants) | Negative Pressure With Procellera | Negative Pressure Therapy Only | Total |
|---|---|---|---|
| Female | 7 | 7 | 14 |
| Male | 7 | 6 | 13 |
| Race (NIH/OMB)(Participants) | Negative Pressure With Procellera | Negative Pressure Therapy Only | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 1 | 7 |
| White | 8 | 12 | 20 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Negative Pressure With Procellera | Negative Pressure Therapy Only | Total |
|---|---|---|---|
| United States | 14 | 13 | 27 |
| Weight(lbs) | Negative Pressure With Procellera | Negative Pressure Therapy Only | Total |
|---|---|---|---|
| Mean | 215.5 ± 66.2 | 202.1 ± 85.1 | 210.6 ± 74.3 |
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Gayle Gordillo