NCT04079998

Procellera® Compared to Standard of Care Treatment in Mitigating Biofilm Formation in Acute Trauma and Burn Wounds

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: The Metis Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trauma-related Wound
• Burn, Partial Thickness

Interventions

Type	Name	Description
DEVICE	Procellera®	Application of Procellera® dressing.
OTHER	Standard of Care	Application of standard of care dressings as prescribed.

Timeline

• Start date: 2019-02-28
• Primary completion: 2020-11-13
• Completion: 2020-12-03
• First posted: 2019-09-06
• Last updated: 2021-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study