NCT02704104

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Arch Therapeutics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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

Conditions

• Skin Neoplasms

Interventions

Type	Name	Description
DEVICE	AC5 Topical Hemostatic Device	Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-03-09
• Last updated: 2018-08-07
• Results posted: 2018-08-07

Locations

1 site across 1 country: Ireland