Activated Carbon Interphase Effect on Biofilm and Total Bacterial Load

Completed · Not applicable

Conditions studied: Wound Infection

In brief

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.

Key facts

Study ID

NCT03461783

Run by

Brock Liden, DPM

People needed

21

Starts

2017-06-26

Expected to finish

2019-02-01

Last updated by the study team

2019-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who are at least 18 years of age.
• Patients of both genders and all races.
• Patients who are in good general health.
• Patients with ankle-brachial index (ABI) measurements greater than 0.5.
• Patients with full-thickness lower extremity diabetic or venous wounds that are not currently being treated with antimicrobial products.
• Patients with full-thickness wounds that are not yet extending to the bone or tendon.
• Patients with wounds present for at least 4 weeks, but no longer than one year.
• Patients with initial bacterial load greater than or equal to 104 colony forming units (CFUs), but less than or equal to 106 CFUs.
• Patients who have voluntarily signed the informed consent form, including HIPAA Authorization.

You may not qualify if…

• Patients who are younger than 18 years of age.
• Patients with autoimmune conditions.
• Patients with ABI measurements less than 0.5 or with lower extremities that are non-interventional or by-passable.
• Patients with full-thickness lower extremity pressure wounds.
• Patients with diabetic or venous wounds that are being treated with antimicrobial products.
• Patients with full-thickness wounds with exposed bone or tendon.
• Patients with wounds present less than 4 weeks or one year or longer.
• Patients with ulcers that had an initial bacterial load less than 104 CFUs or greater than 106 CFUs.
• Patients who are pregnant or lactating.
• Patients with known allergy(ies) to any of the components of the study dressing.
• Patients who are considered by the investigator for any reason to be an unsuitable candidate.
• Patients who are unwilling or unable to follow the follow-up evaluation schedules.
• Patients who refuse to voluntarily sign the informed consent form.

Where it is running

• Circleville Foot & Ankle, LLC — Circleville, Ohio, United States
• Hocking Valley Community Hospital — Logan, Ohio, United States

Full record on ClinicalTrials.gov

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