A Randomized Controlled Single-Blind Investigation to Evaluate the Safety and Performance of the AC5 Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Skin Neoplasms
- Sponsor
- Arch Therapeutics
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Number of Participants With Treatment-emergent Adverse Events Related to Clinical Investigation Product During the 30 Days of Follow-up
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women between the ages of 18 and
- •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investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care.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:
- •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.
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.
Outcomes
Primary Outcomes
Number of Participants With Treatment-emergent Adverse Events Related to Clinical Investigation Product During the 30 Days of Follow-up
Time Frame: 30 Days Post Procedure
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.
Secondary Outcomes
- Time to Hemostasis in Seconds Per Square Centimeter Wound Area(At time of application (Day 0))
- Median Time to Hemostasis (Seconds)(At time of application (Day 0))
- Number of Wounds With ASEPSIS Wound Scores of 0 at Day 7 and Day 30(7 and 30 Days Post Procedure)