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Procellera and Negative Pressure Therapy for Acute Wounds

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ClinicalTrials.gov Identifier: NCT01938066
Recruitment Status : Completed
First Posted : September 10, 2013
Results First Posted : April 21, 2016
Last Update Posted : April 21, 2016
Sponsor:
Collaborator:
Vomaris Innovations
Information provided by (Responsible Party):
Gayle Gordillo, Ohio State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Wound
Interventions Device: Procellera
Device: negative pressure therapy
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Negative Pressure With Procellera Negative Pressure Therapy Only
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 15 15
Completed 14 13
Not Completed 1 2
Arm/Group Title Negative Pressure With Procellera Negative Pressure Therapy Only Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 14 13 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  78.6%
3
  23.1%
14
  51.9%
>=65 years
3
  21.4%
10
  76.9%
13
  48.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 13 participants 27 participants
54.7  (10) 58.3  (12) 56.8  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
Female
7
  50.0%
7
  53.8%
14
  51.9%
Male
7
  50.0%
6
  46.2%
13
  48.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  42.9%
1
   7.7%
7
  25.9%
White
8
  57.1%
12
  92.3%
20
  74.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 13 participants 27 participants
14 13 27
Weight  
Mean (Standard Deviation)
Unit of measure:  Lbs
Number Analyzed 14 participants 13 participants 27 participants
215.5  (66.2) 202.1  (85.1) 210.6  (74.3)
1.Primary Outcome
Title Wound Infection
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Negative Pressure With Procellera Negative Pressure Therapy Only
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 13 12
Measure Type: Number
Unit of Measure: participants
13 12
2.Secondary Outcome
Title Amount of Pain Medication Used (Morphine)
Hide Description will measure the amount of pain medication used (morphine)
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Negative Pressure With Procellera Negative Pressure Therapy Only
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: mg
139.29  (116.05) 178.55  (147.28)
Time Frame [Not Specified]
Adverse Event Reporting Description The use of Procellera presented no risks during the study timeline. The subjects were not placed on Procellera if they have any sensitivity to zinc, silver or have uncontrolled bleeding.
 
Arm/Group Title Negative Pressure With Procellera Negative Pressure Therapy Only
Hide Arm/Group Description

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

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

All-Cause Mortality
Negative Pressure With Procellera Negative Pressure Therapy Only
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Negative Pressure With Procellera Negative Pressure Therapy Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/13 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Negative Pressure With Procellera Negative Pressure Therapy Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/13 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gayle Gordillo
Organization: The Ohio State University
Phone: 6142938566
EMail: gayle.gordillo@osumc.edu
Layout table for additonal information
Responsible Party: Gayle Gordillo, Ohio State University
ClinicalTrials.gov Identifier: NCT01938066    
Other Study ID Numbers: 2013H0028
First Submitted: September 4, 2013
First Posted: September 10, 2013
Results First Submitted: March 25, 2015
Results First Posted: April 21, 2016
Last Update Posted: April 21, 2016