Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04079998 |
Other study ID # |
C.2018.065 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 28, 2019 |
Est. completion date |
December 3, 2020 |
Study information
Verified date |
January 2021 |
Source |
The Metis Foundation |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The objective of the study is to evaluate Procellera® , a novel FDA approved antimicrobial
wound dressing in a prospective, randomized, controlled clinical study. The hypothesis is
that when the dressing is moistened, the low electric field created by moisture-activated
elemental silver and zinc electro-couple will prevent formation of biofilm in wounds or to
disrupt existing biofilm.
Description:
The healing of traumatic wounds, to include burns, can be compromised by the presence of
infection so efforts are made to prevent or diagnose infection early in order to mitigate the
negative impact on healing. Electric stimulation has previously been shown to have both
bacteriostatic and bactericidal effects in wounds. Until now, administering low intensity
electric field/micro-current as a therapy to mitigate biofilm infection and to improve wound
healing was not feasible. In this study the investigators will use Procellera® , a FDA
approved fabric based wireless electroceutical dressing (WED) consisting of a silver-zinc
electro-couple for the prevention of wound biofilm formation. The dressing generates a low
electric field (~1V) upon activation by a moist environment, which mitigates biofilm
formation and promotes wound healing. The objectives of the study are to evaluate the
efficacy of a wireless electroceutical dressing to prevent the formation or disrupting
existing biofilms. The investigators will conduct a prospective, randomized controlled
clinical trial using the Procellera® dressing compared to the standard of care. Treatment
sites will be randomized to either receiving Procellera® or the standard of care treatment.
Objective measurements and assessments will be completed during subject follow-up visits for
up to one month post treatment. This includes biopsies to calculate bacterial load by
assessing colony forming unit (CFU) count and bacterial film visualization using scanning
electron microscopy, histology, clinical assessment of infection, Transepidermal Water Loss
(TEWL) and wound photography.