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=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 10 • n=99 Participants
|
58.3 years
STANDARD_DEVIATION 12 • n=107 Participants
|
56.8 years
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=99 Participants
|
13 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Weight
|
215.5 lbs
STANDARD_DEVIATION 66.2 • n=99 Participants
|
202.1 lbs
STANDARD_DEVIATION 85.1 • n=107 Participants
|
210.6 lbs
STANDARD_DEVIATION 74.3 • n=206 Participants
|
PRIMARY outcome
Timeframe: At the end of 5 daysAt 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 dayswill 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place