Briagen Observational Study

Overview

This research study is evaluating a study product called Briagen™ as a possible treatment for wound healing after Mohs procedure.

Full Title of Study: “Briagen™ Case Study and Observation of Skin Excision Healing in Mohs and Other Dermatological Procedures”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2020

Detailed Description

Briagen, the study product being used in this study, is a natural complex carbohydrate wound dressing for skin wounds created by Mohs surgery. Briagen was developed with the intent to improve healing time and reduce scarring of skin wounds. Briagen seeks to match the mechanical aspects of your skin (thickness, stiffness, hydration, pore size) to assist in the healing process. The purpose of this research study is to observe healing time of Briagen applied to wounds created as a result of Mohs surgery.

Interventions

  • Device: Briagen
    • Natural complex carbohydrate wound dressing for skin wounds

Clinical Trial Outcome Measures

Primary Measures

  • Healing Time
    • Time Frame: 28 days

Participating in This Clinical Trial

Inclusion Criteria

1. Patient seeking treatment for wound created by Mohs or other full thickness skin excisions 2. Over 18 years of age 3. English-speaking 4. Presents for treatment within 24 hours of initial Mohs skin excision procedure. Exclusion Criteria:

1. History of significant wound complications and non-compliance on wound maintenance instructions (infections, disturbing the wound during the healing process, etc.) 2. Known diagnosis of Diabetes 3. Active infection in the wound bed 4. Under 18 years of age

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gemstone Biotherapeutics
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Emily English, PhD, 443-682-7740, info@gemstonebio.com

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