- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04090970
Briagen Observational Study (BOS)
Briagen™ Case Study and Observation of Skin Excision Healing in Mohs and Other Dermatological Procedures
Study Overview
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Emily English, PhD
- Phone Number: 443-682-7740
- Email: info@gemstonebio.com
Study Locations
-
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New Jersey
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Englewood, New Jersey, United States, 07631
- Recruiting
- Dr. David Abramson
-
Contact:
- David Abramson, MD
- Phone Number: 201-568-2977
-
-
North Carolina
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Charlotte, North Carolina, United States, 28207
- Recruiting
- Dermatology, Laser & Vein Specialists of the Carolinas
-
Contact:
- Razia Ludin, MHA,BSc, CCRC
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Principal Investigator:
- Girish Munavalli, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient seeking treatment for wound created by Mohs or other full thickness skin excisions
- Over 18 years of age
- English-speaking
- Presents for treatment within 24 hours of initial Mohs skin excision procedure.
Exclusion Criteria:
- History of significant wound complications and non-compliance on wound maintenance instructions (infections, disturbing the wound during the healing process, etc.)
- Known diagnosis of Diabetes
- Active infection in the wound bed
- Under 18 years of age
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Healing Time
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1001 (Registro Nacional Estudios Clinicos (RNEC))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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