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Briagen Observational Study (BOS)

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ClinicalTrials.gov Identifier: NCT04090970
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Gemstone Biotherapeutics

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

Condition or disease Intervention/treatment
Mohs Surgery Device: Briagen

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.


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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gemstone Biotherapeutics Briagen™ Case Study and Observation of Mohs Excision Healing
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020

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


Primary Outcome Measures :
  1. Healing Time [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient seeking treatment for wound created by Mohs skin excision
Criteria

Inclusion Criteria:

  1. Patient seeking treatment for wound created by Mohs skin excision
  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. Locations where the subject cannot reach/access the wound or take care of the wound themselves, unless the subject has a live-in caregiver who is trained on instructions for wound maintenance
  2. locations on restrictive clothing seams, underwear bands/seams, bra shoulder straps/bra torso line, breasts/buttocks, etc.
  3. history of significant wound complications and non-compliance on wound maintenance instructions (infections, disturbing the wound during the healing process, etc.)
  4. active infection in the wound bed
  5. under 18 years of age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090970


Contacts
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Contact: Emily English, PhD 443-682-7740 info@gemstonebio.com

Locations
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United States, New Jersey
Dr. David Abramson Recruiting
Englewood, New Jersey, United States, 07631
Contact: David Abramson, MD    201-568-2977      
Sponsors and Collaborators
Gemstone Biotherapeutics

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Responsible Party: Gemstone Biotherapeutics
ClinicalTrials.gov Identifier: NCT04090970     History of Changes
Other Study ID Numbers: 1001
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No