Procellera® Compared to Standard of Care Treatment in Mitigating Biofilm Formation in Acute Trauma and Burn Wounds
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|ClinicalTrials.gov Identifier: NCT04079998|
Recruitment Status : Completed
First Posted : September 6, 2019
Last Update Posted : January 22, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Trauma-related Wound Burn, Partial Thickness||Device: Procellera® Other: Standard of Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will have two wound sites that will be randomized to receive either the standard of care treatment or the Procellera® (electroceutical) dressing.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Biopsies obtained will be sent to Indiana University for blinded processing and analysis.|
|Official Title:||A Prospective, Randomized, Controlled Study to Determine the Superiority of a Fabric-based Wireless Electroceutical Dressing, Procellera® Compared to Standard of Care Treatment in Mitigating Biofilm Formation in Acute Trauma and Burn Wounds|
|Actual Study Start Date :||February 28, 2019|
|Actual Primary Completion Date :||November 13, 2020|
|Actual Study Completion Date :||December 3, 2020|
Experimental: Procellera® dressing
The Procellera® dressing will be applied to the wound site after standard of care cleaning and debridement. The dressing will be maintained according to the manufacturer's instructions for use.
Application of Procellera® dressing.
Active Comparator: Standard of Care
The Standard of care as prescribed will be followed for the dressing application for the wound site. Dressings will be applied to the wound site after standard of care cleaning and debridement.
Other: Standard of Care
Application of standard of care dressings as prescribed.
- Presence of biofilm [ Time Frame: Day seven ]Presence of biofilm will be assessed by obtaining a wound biopsy and analyzing with Scanning Electron Microscopy.
- Rate of eradication of biofilm production [ Time Frame: Day 7 ]Presence of biofilm will be assessed by obtaining a wound biopsy and analyzing with Scanning Electron Microscopy.
- Incidence of infection [ Time Frame: Day 0-30 ]Wounds will be assessed for the presence of clinical evidence indicating infection.
- Percent epithelialization [ Time Frame: Day 7 ]The percentage of epitheliazation will be assessed utilizing clinical assessments and the Silhouette Star wound camera.
- Quality of healing [ Time Frame: Day 30 ]Quality of healing post-epithelialization as measured by the validated Patient Observer Scar Assessment Scale (POSAS)
- Quantitative bacterial load calculation [ Time Frame: Day 7 ]Quantitative bacterial load will be assessed by obtaining a wound biopsy and analyzed by performing colony forming unit counts
- Incidence of adverse events [ Time Frame: Day 0-30 ]The incidence of adverse events will be reported to assess safety.
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 18-65 years of age
- Willing and able to provide informed consent
- Participant has acute partial-thickness or full-thickness wounds caused by trauma or partial-thickness burns that are ≥ 300 cm2 in size in one contiguous area or two separate wound sites ≥ 150 cm2 each
- Active malignancy or immunosuppressive therapy
- Current systemic steroid use
- Known allergy or sensitivity to silver or zinc
- Participant's proposed study wound site has any of the following conditions:
- Location is on the hands, face or feet
- Full-thickness burn wounds
- Exposure of visceral organs
- Exposure of hardware or prosthetic exposure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04079998
|United States, Texas|
|Brooke Army Medical Center|
|Fort Sam Houston, Texas, United States, 78234|
|Responsible Party:||The Metis Foundation|
|Other Study ID Numbers:||
|First Posted:||September 6, 2019 Key Record Dates|
|Last Update Posted:||January 22, 2021|
|Last Verified:||January 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
Wounds and Injuries