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

NCT ID: NCT04079998

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2020-12-03

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Procellera®

Intervention Type: DEVICE

Application of Procellera® dressing.

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Application of standard of care dressings as prescribed.

Interventions

Procellera®

Application of Procellera® dressing.

Intervention Type: DEVICE

Standard of Care

Application of standard of care dressings as prescribed.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: collaborator

The Metis Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36855334 (View on PubMed)

Other Identifiers

C.2018.065

Identifier Type: -

Identifier Source: org_study_id