Activated Carbon Interphase Effect on Biofilm and Total Bacterial Load

NCT03461783 | Completed FDA Device

• 1 other identifier: Carbon Dressing
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Total Bacterial Load

  Total bacterial load will be measured total colony forming units (CFUs) as determined from laboratory findings

  4 weeks

Secondary Outcomes (4)

• Pain Associated with Wound

  4 weeks

• Wound Bed Inflammation

  4 weeks

• Wound Odor

  4 weeks

• Wound Size Progression

  4 weeks

Study Arms (2)

Zorflex Activated Carbon Dressing

EXPERIMENTAL

Patients randomized into the experimental group will only be treated using an activated carbon dressing (Zorflex® Activated Carbon Cloth Dressing; Chemviron Carbon Cloth Carbon, West Midlands, United Kingdom; a division of Calgon Carbon Corporation, Pittsburgh, PA) for wet wounds or with saline and Zorflex® Activated Carbon Cloth Dressing for dry wounds.

Device: Zorflex Activated Carbon Dressing

Standard of Care for Wound Care

ACTIVE COMPARATOR

Patients with wet wounds randomized into the control group will be treated using foam, calcium alginate or compressive dressings, whereas those with dry wounds will be treated with hydrogel and compressive dressings.

Device: Standard of Care

Interventions

Zorflex Activated Carbon Dressing DEVICE

Antimicrobial dressing

Zorflex Activated Carbon Dressing

Standard of Care DEVICE

foam, calcium alginate, hydrogel, or compressive dressings

Standard of Care for Wound Care

Eligibility Criteria

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

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.

Sponsors & Collaborators

• Brock Liden, DPM: lead

Study Sites (2)

Circleville Foot & Ankle, LLC

Circleville, Ohio, 43113, United States

Location

Hocking Valley Community Hospital

Logan, Ohio, 43138, United States

Location

Related Publications (7)

• Isseroff RR, Dahle SE. Electrical Stimulation Therapy and Wound Healing: Where Are We Now? Adv Wound Care (New Rochelle). 2012 Dec;1(6):238-243. doi: 10.1089/wound.2011.0351.

  PMID: 24527312 BACKGROUND

• Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.

  PMID: 14622683 BACKGROUND

• Kalinski CK, Schnepf M, Laboy D, Hernandez L, Nusbaum J, McGrinder B, Comfort C, Alvarez OM. Effectiveness of a Topical Formulation Containing Metronidazole for Wound Odor and Exudate Control. Wounds. 2005;17(4):84-90.

  BACKGROUND

• Miller MS, Markey L, Yoder R. A link to reducing the stink - use of a unique carbon based textile dressing Zorflex® to promote healing while significantly reducing wound odor in diabetic and venous ulcers - a case series of three. Presented as a poster at the Wild on Wounds (WOW) National Wound Conference, Las Vegas, NV, Aug 31-Sept 3, 2016.

  BACKGROUND

• Murphy N. Reducing infection in chronic leg ulcers with an activated carbon cloth dressing. Br J Nurs. 2016 Jun 23;25(12):S38-44. doi: 10.12968/bjon.2016.25.12.S38.

  PMID: 27345081 BACKGROUND

• Young S, Gray S, and Hampton S. A retrospective study to evaluate the effect of an activated carbon dressing on chronic wounds. Presented as an e-poster at the 2016 European Wound Management Association (EWMA), Bremen, Germany, May 11-13, 2016.

  BACKGROUND

• Zorflex® Instructions for Use. http://zorflex.com/what-is-zorflex/, accessed on January 17, 2017.

  BACKGROUND

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Brock Liden, DPM

  Circleville Foot & Ankle LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Invesigator

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: March 12, 2018
• Study Start: June 26, 2017
• Primary Completion: August 3, 2018
• Study Completion: February 1, 2019
• Last Updated: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)