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

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.

Study Overview

• Status: Completed
• Conditions: Trauma-related Wound; Burn, Partial Thickness
• Intervention / Treatment: Device: Procellera®; Other: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Brooke Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Procellera®; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of biofilm	Presence of biofilm will be assessed by obtaining a wound biopsy and analyzing with Scanning Electron Microscopy.	Day seven
Rate of eradication of biofilm production	Presence of biofilm will be assessed by obtaining a wound biopsy and analyzing with Scanning Electron Microscopy.	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of infection	Wounds will be assessed for the presence of clinical evidence indicating infection.	Day 0-30
Percent epithelialization	The percentage of epitheliazation will be assessed utilizing clinical assessments and the Silhouette Star wound camera.	Day 7
Quality of healing	Quality of healing post-epithelialization as measured by the validated Patient Observer Scar Assessment Scale (POSAS)	Day 30
Quantitative bacterial load calculation	Quantitative bacterial load will be assessed by obtaining a wound biopsy and analyzed by performing colony forming unit counts	Day 7
Incidence of adverse events	The incidence of adverse events will be reported to assess safety.	Day 0-30

Collaborators and Investigators

• Sponsor: The Metis Foundation
• Collaborators: Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2019
• Primary Completion (Actual): November 13, 2020
• Study Completion (Actual): December 3, 2020

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: September 3, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Burns; Wounds and Injuries
• Other Study ID Numbers: C.2018.065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes