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

NCT02704104 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-08-07

Study results available
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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.

Conditions

  • Skin Neoplasms

Interventions

DEVICE

AC5 Topical Hemostatic Device

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

Sponsors & Collaborators

  • Arch Therapeutics

    lead INDUSTRY

Principal Investigators

  • Jack Kelly, MD · Professor of Surgery

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02704104 on ClinicalTrials.gov