Mohs SurgeryBOSNCT04090970
Briagen Observational Study
An observational study of Mohs Surgery, run by Gemstone Biotherapeutics at 2 sites in United States.
Trial summary
This research study is evaluating a study product called Briagen™ as a possible treatment for wound healing after Mohs procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mohs Surgery
- What is being tested?
- Briagen
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Aug 2019to May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient seeking treatment for wound created by Mohs skin excision
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
Razia Ludin, MHA,BSc, CCRC
Girish Munavalli, MD
- Recruiting
Dr. David Abramson
Englewood, New Jersey, 07631
David Abramson, MD, 201-568-2977
About this study
Official title: 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.
Read the 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.
- Conditions
- Mohs Surgery
- Being tested
- Briagen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BriagenDevice
Natural complex carbohydrate wound dressing for skin wounds
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Time
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start26 Aug 2019
- Primary completionMar 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mohs SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gemstone Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090970
- Sponsor's protocol ID
- 1001
- Acronym
- BOS
- Status last verified
- Dec 2019
- First submitted
- 13 Sep 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Briagen™ Case Study and Observation of Skin Excision Healing in Mohs and Other Dermatological Procedures
- ClinicalTrials.gov ID
- NCT04090970
- Acronym / sponsor ID
- BOS / 1001
- Conditions
- Mohs Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gemstone BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is evaluating a study product called Briagen™ as a possible treatment for wound healing after Mohs procedure.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient seeking treatment for wound created by Mohs skin excision
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BriagenNatural complex carbohydrate wound dressing for skin wounds | Device | – |
Primary outcome
Healing Time
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Mohs Surgery
Not yet recruitingPhase 1
Amnion Membrane Powder Mohs Study
Wound Heal
Not yet recruiting
Cyanoacrylate Skin Adhesive After Mohs Surgery or Wide Local Excision
Surgical Site Infection, Skin Cancer
Not yet recruitingPhase 2
The Effects of Timolol On Healing and Cosmesis of Mohs Scalp Wounds: An Open Label Trial
Surgical Wounds, Mohs Surgery
Not yet recruiting
Intraoperative CO₂ (Carbon Dioxide)
Wound Edges
Not yet recruitingPhase 4
Skin Subs vs Secondary Intention
Skin Substitutes, Secondary Intention Healing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mohs Surgery, run by Gemstone Biotherapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emily English, PhD (443-682-7740, info@gemstonebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing Time (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.