Trial Outcomes & Findings for Procellera and Negative Pressure Therapy for Acute Wounds (NCT NCT01938066)

NCT ID: NCT01938066

Last Updated: 2016-04-21

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: At the end of 5 days
• Results posted on: 2016-04-21

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	15	15
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Procellera and Negative Pressure Therapy for Acute Wounds

Baseline characteristics by cohort

Measure	Negative Pressure With Procellera n=14 Participants 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	Negative Pressure Therapy Only n=13 Participants 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	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Age, Continuous	54.7 years STANDARD_DEVIATION 10 • n=5 Participants	58.3 years STANDARD_DEVIATION 12 • n=7 Participants	56.8 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	13 participants n=7 Participants	27 participants n=5 Participants
Weight	215.5 lbs STANDARD_DEVIATION 66.2 • n=5 Participants	202.1 lbs STANDARD_DEVIATION 85.1 • n=7 Participants	210.6 lbs STANDARD_DEVIATION 74.3 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Negative Pressure With Procellera n=13 Participants 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	Negative Pressure Therapy Only n=12 Participants 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
Wound Infection	13 participants	12 participants

SECONDARY outcome

Timeframe: 5 days

will measure the amount of pain medication used (morphine)

Outcome measures

Measure	Negative Pressure With Procellera n=14 Participants 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	Negative Pressure Therapy Only n=13 Participants 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
Amount of Pain Medication Used (Morphine)	139.29 mg Standard Deviation 116.05	178.55 mg Standard Deviation 147.28

Adverse Events

Negative Pressure With Procellera

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Negative Pressure Therapy Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gayle Gordillo

The Ohio State University

Phone: 6142938566

Email: gayle.gordillo@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place