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

Trauma-related Wound Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04079998
• Other study ID #: C.2018.065
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 3, 2020
• Est. primary completion date: November 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn, Partial Thickness
• Burns
• Trauma-related Wound
• Wounds and Injuries

Intervention

Device:
• Procellera®
Application of Procellera® dressing.

Other:
• Standard of Care
Application of standard of care dressings as prescribed.

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Fort Sam Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The Metis Foundation	Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of biofilm	Presence of biofilm will be assessed by obtaining a wound biopsy and analyzing with Scanning Electron Microscopy.	Day seven
Primary	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	Incidence of infection	Wounds will be assessed for the presence of clinical evidence indicating infection.	Day 0-30
Secondary	Percent epithelialization	The percentage of epitheliazation will be assessed utilizing clinical assessments and the Silhouette Star wound camera.	Day 7
Secondary	Quality of healing	Quality of healing post-epithelialization as measured by the validated Patient Observer Scar Assessment Scale (POSAS)	Day 30
Secondary	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
Secondary	Incidence of adverse events	The incidence of adverse events will be reported to assess safety.	Day 0-30