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

• ClinicalTrials.gov Identifier: NCT04079998
• Recruitment Status: Completed
• First Posted: September 6, 2019
• Last Update Posted: January 22, 2021
• Sponsor: The Metis Foundation
• Collaborator: Indiana University
• Information provided by (Responsible Party): The Metis Foundation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Trauma-related Wound; Burn, Partial Thickness	Device: Procellera®; Other: Standard of Care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 38 participants
• Allocation: Randomized
• 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.
• Primary Purpose: Treatment
• 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

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Presence of biofilm [ Time Frame: Day seven ]
   Presence of biofilm will be assessed by obtaining a wound biopsy and analyzing with Scanning Electron Microscopy.
2. 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.

Secondary Outcome Measures :

1. Incidence of infection [ Time Frame: Day 0-30 ]
   Wounds will be assessed for the presence of clinical evidence indicating infection.
2. Percent epithelialization [ Time Frame: Day 7 ]
   The percentage of epitheliazation will be assessed utilizing clinical assessments and the Silhouette Star wound camera.
3. Quality of healing [ Time Frame: Day 30 ]
   Quality of healing post-epithelialization as measured by the validated Patient Observer Scar Assessment Scale (POSAS)
4. 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
5. Incidence of adverse events [ Time Frame: Day 0-30 ]
   The incidence of adverse events will be reported to assess safety.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Texas

Brooke Army Medical Center

Fort Sam Houston, Texas, United States, 78234

Sponsors and Collaborators

The Metis Foundation

Indiana University

More Information

• Responsible Party: The Metis Foundation
• ClinicalTrials.gov Identifier: NCT04079998
• Other Study ID Numbers: C.2018.065
• First Posted: September 6, 2019
• 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

Additional relevant MeSH terms:

Wounds and Injuries; Burns