Briagen Observational Study

Mohs Surgery Clinical Trial

— BOS  

Official title:

Briagen™ Case Study and Observation of Skin Excision Healing in Mohs and Other Dermatological Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04090970
• Other study ID #: 1001
• Status: Recruiting
• Start date: August 26, 2019
• Est. completion date: May 2020

Study information

• Verified date: December 2019
• Source: Gemstone Biotherapeutics
• Contact: Emily English, PhD
• Phone: 443-682-7740
• Email: info[@]gemstonebio.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mohs Surgery

Intervention

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

Locations

Country	Name	City	State
United States	Dermatology, Laser & Vein Specialists of the Carolinas	Charlotte	North Carolina
United States	Dr. David Abramson	Englewood	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Gemstone Biotherapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing Time		28 days