Briagen Observational Study (BOS)

December 13, 2019 updated by: Gemstone Biotherapeutics

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Recruiting
        • Dr. David Abramson
        • Contact:
          • David Abramson, MD
          • Phone Number: 201-568-2977
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Recruiting
        • Dermatology, Laser & Vein Specialists of the Carolinas
        • Contact:
          • Razia Ludin, MHA,BSc, CCRC
        • Principal Investigator:
          • Girish Munavalli, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient seeking treatment for wound created by Mohs skin excision

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 26, 2019

Primary Completion (ANTICIPATED)

March 1, 2020

Study Completion (ANTICIPATED)

May 1, 2020

Study Registration Dates

First Submitted

September 13, 2019

First Submitted That Met QC Criteria

September 13, 2019

First Posted (ACTUAL)

September 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

December 1, 2019

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Mohs Surgery

3
Subscribe