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

Brock Liden, DPM

Status

Withdrawn

Conditions

Surgical Wound, Healed

Treatments

Device: Antimicrobial Alginate Dressing with Silver

Device: Knitted Cellulose Acetate Mesh

Device: Activated Carbon Cloth Dressing

Study type

Interventional

Identifiers

NCT04038671

Liden20191

Details and patient eligibility

About

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.

Full description

Postoperative incision complications and surgical site infections are risks for patients undergoing surgery. While most surgical incisions heal without complications, postoperative complications, such as erythema, blistering, maceration, scarring, necrosis, and infection, interfere with the normal healing process. Preventing such complications must be a priority, as they may contribute to longer recovery times, as well as increased hospital stays, costs, and morbidity.

Ideally, surgical incision dressings should exhibit the following characteristics:

promote a moist environment;
be absorbent, but transparent so fluid accumulation and other complications may be observed;
be permeable;
be low adherent to facilitate removal from skin;
act as a complete barrier to bacteria and water, but not to moisture vapor; and
feature some flexibility to avoid restricted limb movement and postoperative edema in the incision area [Chen et al; Collins].

However, despite advances in wound dressing designs, there is no consensus regarding the ideal surgical incision dressing. One emerging dressing modality exhibits these key characteristics. This novel activated carbon cloth dressing is low-adherent, comprised of 100% pure activated carbon and also conforms to body contours to maintain contact with the incision surface.

This randomized, prospective clinical trial will compare this activated carbon cloth dressing to two other commercially-available wound dressings, including a non-adherent antimicrobial alginate dressing with silver and a non-adhering knitted cellulose acetate mesh dressing soaked in Povidone-iodine. The primary endpoint is incision coaptation/closure. Secondary endpoints include incision/scar appearance, such as inflammation and edema, odor, pain, patient satisfaction, and number of dressing changes.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 3 patient groups

Activated Carbon Dressing

Experimental group

Description:

A low-adherent, comprised of 100% pure activated carbon and also conforms to body contours to maintain contact with the incision surface. The dressing may be used either dry or moistened with sterilized water over dry or discharging, partial and full thickness wounds.

Treatment:

Device: Activated Carbon Cloth Dressing

Knitted Cellulose Acetate Mesh

Active Comparator group

Description:

a non-adhering dressing, comprised of a knitted cellulose acetate mesh impregnated with a specially-formulated petrolatum emulsion.

Treatment:

Device: Knitted Cellulose Acetate Mesh

Antimicrobial Alginate Dressing with Silver

Active Comparator group

Description:

a non-adherent antimicrobial alginate dressing with silver