Wound Infection Clinical Trial
Official title:
Activated Carbon Interphase Effect on Biofilm and Total Bacterial Load: A Randomized Pilot Study
Verified date | February 2019 |
Source | Liden, Brock, DPM |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | February 1, 2019 |
Est. primary completion date | August 3, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Circleville Foot & Ankle, LLC | Circleville | Ohio |
United States | Hocking Valley Community Hospital | Logan | Ohio |
Lead Sponsor | Collaborator |
---|---|
Brock Liden, DPM |
United States,
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. Review. — View Citation
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. — View Citation
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.
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.
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. — View Citation
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.
Zorflex® Instructions for Use. http://zorflex.com/what-is-zorflex/, accessed on January 17, 2017.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Bacterial Load | Total bacterial load will be measured total colony forming units (CFUs) as determined from laboratory findings | 4 weeks | |
Secondary | Pain Associated with Wound | Patients will rate their pain on a Visual Analog Scale (VAS) that consists of a 10cm (100mm) line with the descriptor "no pain" positioned at the left pole and the descriptor "worst pain imaginable" positioned at the right pole. | 4 weeks | |
Secondary | Wound Bed Inflammation | Protease laboratory measurements of the wound bed will be use to elevate wound bed inflammation. | 4 weeks | |
Secondary | Wound Odor | Wound odor will be assessed by both the patient and investigator using Visual Analog Scale (VAS) that consists of a 10cm (100mm) line with the descriptor "no odor" positioned at the left pole and the descriptor "extremely offensive odor" positioned at the right pole. | 4 weeks | |
Secondary | Wound Size Progression | Wound size measurements obtained from the software utilized by the eKare inSight™ (eKare, Inc., Fairfax, VA) system will be used to determine wound bed healing progression. | 4 weeks |
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