Activated Carbon Interphase Effect on Surgical Incisions vs.Two Common Wound Dressings

Withdrawn before enrolling · Not applicable

Conditions studied: Surgical Wound, Healed

In brief

This randomized, prospective study evaluates incision closure, post-surgical wound complications, dressing changes, incision/scar appearance, pain associated with dressing changes, and patient satisfaction rates of an activated carbon dressing versus two commercially available wound dressings.

Key facts

Study ID

NCT04038671

Run by

Brock Liden, DPM

People needed

0

Starts

2019-01-07

Expected to finish

2020-02-01

Last updated by the study team

2020-02-24

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 undergoing primary, uni- or bilateral operative procedures of the forefoot, midfoot, non-heel posterior foot, ankle, and lower extremity and whose incisions are linear and at least 2 inches in length.
• Patients who are in good general health.
• Patients with no systemic or local active dermatologic disease, such as, but not limited to eczema, psoriasis, skin cancer, scleroderma, or chronic urticaria.
• Patients with vascular disorders must have been treated surgically to be considered for inclusion.
• Patients with diabetes must have ankle brachial index measurements greater than 0.6 to be considered for inclusion.
• 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 undergoing operative procedures involving the heel or whose incisions are non-linear, such as those with curved arches or "S" configurations, and/or are less than 2 inches in length.
• Patients with previous operative procedure around the same area or joint.
• Patients with systemic or local active dermatologic disease, such as but limited to eczema, psoriasis, skin cancer, scleroderma, or chronic urticaria, that might interfere with surgical site evaluation.
• Patients with history of previous local infection.
• Patients with autoimmune conditions.
• Patients with known allergies or topical hypersensitivities to silver or any other components of the study dressings.
• Patients currently taking steroids or other immune modulators know to affect wound healing.
• Patients with vascular disorders that are non-interventional.
• Patients with diabetes who have ankle brachial index measurements less than 0.6 or lower extremities that are non-interventional or by-passable.
• 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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