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

Skin Neoplasms Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02704104
Study type Interventional
Source ARCH Therapuetics
Contact
Status Completed
Phase N/A
Start date February 2016
Completion date June 2016
View Details
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