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

NCT04079998 | Completed FDA Device

• 1 other identifier: C.2018.065
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma-related Wound; Burn, Partial Thickness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Incidence of infection

  Day 0-30

• Percent epithelialization

  Day 7

• Quality of healing

  Day 30

• Quantitative bacterial load calculation

  Day 7

• Incidence of adverse events

  Day 0-30

Study Arms (2)

Procellera® dressing

EXPERIMENTAL

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®

Standard of Care

ACTIVE COMPARATOR

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

Interventions

Procellera® DEVICE

Application of Procellera® dressing.

Procellera® dressing

Standard of Care OTHER

Application of standard of care dressings as prescribed.

Standard of Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Metis Foundation: lead
• Indiana University: collaborator

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (1)

• Chan RK, Nuutila K, Mathew-Steiner SS, Diaz V, Anselmo K, Batchinsky M, Carlsson A, Ghosh N, Sen CK, Roy S. A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness of a Fabric-Based Wireless Electroceutical Dressing Compared to Standard-of-Care Treatment Against Acute Trauma and Burn Wound Biofilm Infection. Adv Wound Care (New Rochelle). 2024 Jan;13(1):1-13. doi: 10.1089/wound.2023.0007. Epub 2023 Apr 11.

  PMID: 36855334 DERIVED

MeSH Terms

Conditions

Burns

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Biopsies obtained will be sent to Indiana University for blinded processing and analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will have two wound sites that will be randomized to receive either the standard of care treatment or the Procellera® (electroceutical) dressing.

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: September 6, 2019
• Study Start: February 28, 2019
• Primary Completion: November 13, 2020
• Study Completion: December 3, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)