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Hemostatics

The intervention in this arm is the application of a topical hemostatic agent (AC5) to a freshly excised skin lesion

The intervention in this arm is the application of saline (Control) to a freshly excised skin lesion

Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient

AC5 Topical Hemostatic Device

Jack Kelly, MD

This study is designed to monitor patient safety after excision of skin lesions and subsequent application of AC5 topical hemostatic agent and to assess the performance of AC5 for controlling bleeding in skin wounds.

This is a randomized, controlled single-blind pilot study to evaluate the safety and performance of AC5 following excision of lesions from the trunk or upper limbs under local anesthetic, in patients currently prescribed or not prescribed antiplatelet monotherapy.

Each patient had sequential shave excision of two lesions (one treatment, one Control) at the same sitting. The sequence of wound treatment (AC5 first or Control first) was randomized.

Study and Control treatments were administered immediately after lesion excision, followed by determination of time to hemostasis (TTH), and application of an occlusive water-resistant dressing

Safety and Performance Evaluation of the Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions

A Randomized Controlled Single-Blind Investigation to Evaluate the Safety and Performance of the AC5 Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions

Local reactions to clinical investigation product (pain, edema, rash, cellulitis, localized infectious processes, other) detected during clinical investigation follow up.

Systemic reactions after administration of clinical investigation product (fever, allergic reaction, anaphylaxis or any clinical untoward event) detected during clinical investigation follow up.

Measure of time from application of treatment or control to the wound, to bleeding cessation

Measure of time from application of treatment or control to the wound, to bleeding cessation/ divided by wound area

The Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay longer than 14 days (ASEPSIS) Wound Score (reference 1) was used to assess wound healing and overall wound sepsis. This multipoint system is reported as a total score ranging from 0 to 30 points in the first 7 days postoperatively. Additional points after 7 days can be added for additional treatments such as use of antibiotics, drainage of pus under local anesthesia, and debridement of the wound; and isolation of bacteria or duration of stay, for a total score of from 0 to 70 points by day 30. Total scores from 0-10 indicate satisfactory healing, from 11 to 20=disturbance of healing, from 21 to 30=minor wound infection, from 31 to 40=moderate wound infection, and \>40 points signifies severe infection. For this study, the number of wounds with ASEPSIS score = 0 was counted.

Arch Therapeutics

Adverse events were assessed immediately after treatment (Day 0), Day 7, and Day 30.

The intervention in this arm is the application of a topical hemostatic agent (AC5) to a freshly excised skin lesion

AC5 Hemostatic agent: Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient

The intervention in this arm is the application of saline (Control) to a freshly excised skin lesion

AC5 Hemostatic agent: Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient

Control

Characteristics of the 46 patients enrolled in the study

Overall

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Ireland

Region of Enrollment

Antiplatelet therapy

Medical/Scientific Affairs

The intervention in this arm is the randomized application of a topical hemostatic device (AC5) to one of two freshly excised lesions in each patient. Number in this arm refers to number of lesions

The intervention in this arm is the randomized application of saline (Control) to one of two freshly excised lesions in each patient. Number in this arm refers to lesions

Number of Participants With Treatment-emergent Adverse Events Related to Clinical Investigation Product During the 30 Days of Follow-up

Analysis is performed per wound (2/patient, one randomized to AC5 the second to control), that is, 46 patients with a total of 96 wounds.

Median Time to Hemostasis (Seconds)

Time to Hemostasis in Seconds Per Square Centimeter Wound Area

Day 7

Day 30

The intervention in this arm is the randomized application of a topical hemostatic device (AC5) to one of two freshly excised lesions in each patient. Number in this arm refers to number of wounds

Wounds Treated With AC5 Topical Hemostatic Device

The intervention in this arm is the randomized application of saline (Control) to one of two freshly excised lesions in each patient. Number in this arm refers to wounds

Wounds Treated With Control

Number of Wounds With ASEPSIS Wound Scores of 0 at Day 7 and Day 30

Taking antiplatelet therapy

Not taking antiplatelet therapy

The overall number of patients is 46, 10 of whom were taking anti platelet therapy at the time of the procedure.

Time to Hemostasis in Patients Who Were Taking or Not Taking Anti Platelet Medication

All study participants had two freshly excised lesions, each randomized to either application of a topical hemostatic device (AC5) or control (saline) treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Performance Evaluation of the Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions	NCT02704104	Skin Neoplasms	AC5 Topical Hem...	18 Years - 85 Years	Arch Therapeutics
Safety and Performance Evaluation of the Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions	NCT02704104	Skin Neoplasms	AC5 Topical Hem...	18 Years - 85 Years	Arch Therapeutics
Safety and Performance Evaluation of the Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions	NCT02704104	Skin Neoplasms	AC5 Topical Hem...	18 Years - 85 Years	Arch Therapeutics

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