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Activated Carbon Interphase Effect on Biofilm and Total Bacterial Load

NCT03461783 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-02-27

No results posted yet for this study

Summary

The purpose of this randomized, prospective study is to evaluate how this activated carbon dressing affects the total bacterial load and biofilm in a wound bed in wounds of the lower extremity and foot. We anticipate that the use of Zorflex® Activated Carbon Cloth dressing will maintain the bacterial burden in the wound bed below the level of critical colonization, with potential secondary benefits of pain reduction, decrease in inflammation, and control of odor. Wound bed healing progression/acceleration also will be assessed.

Conditions

  • Wound Infection

Interventions

DEVICE

Zorflex Activated Carbon Dressing

Antimicrobial dressing

DEVICE

Standard of Care

foam, calcium alginate, hydrogel, or compressive dressings

Sponsors & Collaborators

  • Brock Liden, DPM

    lead INDIV

Principal Investigators

  • Brock Liden, DPM · Circleville Foot & Ankle LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-26
Primary Completion
2018-08-03
Completion
2019-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03461783 on ClinicalTrials.gov