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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Skin Neoplasms

Intervention / Treatment
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* Device: AC5 Topical Hemostatic Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women between the ages of 18 and 85. Voluntary written informed consent, given before performance of any clinical investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care. Scheduled for excision of 2 (two) or more skin lesions from their trunk or upper limbs (defined as lying below the level of the inferior border of the patient's mandible). If subjects is currently prescribed an antiplatelet therapy, it must from one of the following therapies at levels as per hospital protocol: Antiplatelet monotherapy with one of the following agents: Aspirin Clopidogrel (thienopyridine-class antiplatelet agent) Ticagrelor Dipyridamole Female subjects must meet at least one of the following additional criteria: Surgically sterile with bilateral tubal ligation or hysterectomy. Post-menopausal for at least one year. If of child-bearing potential, practicing an acceptable method of birth control for the duration of the clinical investigation as judged by the Investigator, such as condoms, foams, jellies, diaphragm, intrauterine device or abstinence. Subjects willing to undergo pre-and post-clinical investigation blood and urine collection, physical exams and laboratory investigations. Exclusion Criteria: Active infection as demonstrated by temperature > 37.5 C and clinical features of active infection. Wound expected to expose bone or tendon. Wound expected to require topical antibiotics. Know contraindication or reaction to Tegaderm use. Presence of malignancy or clinical expectation of malignancy based on examination. Known immunosuppression or taking immunosuppressive agents including systemic steroids. Plan for adjunctive flap or graft procedure to obtain closure of the wound(s) subject to this study. History of severe co-morbidity with expected patient survival ≤ 6 months. Pregnancy or lactation Intake of investigational drugs within 28 days prior to enrollment. Currently taking oral anticoagulants History of concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol. History of clinically significant, active disease (within 12 months prior to enrollment) of the pulmonary, gastrointestinal, neurological, genitourinary, renal, or haematological system, that in the opinion of the Principal Investigator, may confound the results of the trial or pose additional risk to the subject following the administration of AC5. History of clinically significant cardiac disorder, defined as: acute coronary syndrome, congestive heart failure (NYHA class III/IV), diagnosis of unstable angina pectoris, cerebral stroke and or myocardial infarction within the last 12 months or planned coronary or carotid revascularisation procedures anytime through 30 Day follow-up. History of severe uncontrolled treated or untreated hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg). Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel. Presence of significant cognitive impairment (Mini Mental Status Examination <22) or mental incapacity. Unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with trial site personnel. Known or suspected active abuse of alcohol, narcotics or non-prescription drugs. Other planned surgical procedures within 30 days prior to or 30 days post-index procedure. Prior enrollment in this AC5 clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AC5 Topical Hemostatic Device<br>The intervention in this arm is the application of a topical hemostatic agent (AC5) to a freshly excised skin lesion | Device: AC5 Topical Hemostatic Device<br>* Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient<br>|
| Placebo Comparator: Control<br>The intervention in this arm is the application of saline (Control) to a freshly excised skin lesion | Device: AC5 Topical Hemostatic Device<br>* Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-emergent Adverse Events Related to Clinical Investigation Product During the 30 Days of Follow-up | 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. | 30 Days Post Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Time to Hemostasis (Seconds) | Measure of time from application of treatment or control to the wound, to bleeding cessation | At time of application (Day 0) | 
| Time to Hemostasis in Seconds Per Square Centimeter Wound Area | Measure of time from application of treatment or control to the wound, to bleeding cessation/ divided by wound area | At time of application (Day 0) | 
| Number of Wounds With ASEPSIS Wound Scores of 0 at Day 7 and Day 30 | 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. | 7 and 30 Days Post Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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topical hemostat, self-assembling peptide barrier