Clinical trial NCT04079998: Procellera® Compared to Standard of Care Treatment in Mitigating Biofilm Formation in Acute Trauma and Burn Wounds
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma-related Wound
Burn, Partial Thickness
Lead sponsor: The Metis Foundation
Sponsor class: OTHER
Collaborators: name: Indiana University
First posted: 2019-09-06
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Pregnancy
* Prisoner
* 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

Primary outcomes:
measure: Presence of biofilm
timeFrame: Day seven
measure: Rate of eradication of biofilm production
timeFrame: Day 7
Secondary outcomes:
measure: Incidence of infection
timeFrame: Day 0-30
measure: Percent epithelialization
timeFrame: Day 7
measure: Quality of healing
timeFrame: Day 30
measure: Quantitative bacterial load calculation
timeFrame: Day 7
measure: Incidence of adverse events
timeFrame: Day 0-30
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
References: