Briagen Observational Study

NCT ID: NCT04090970

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-26

Study Completion Date

2020-05-31

Brief Summary

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

Detailed Description

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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

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Mohs Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Briagen

Natural complex carbohydrate wound dressing for skin wounds

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gemstone Biotherapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dr. David Abramson

Englewood, New Jersey, United States

Site Status RECRUITING

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Emily English, PhD

Role: CONTACT

Phone: 443-682-7740

Email: [email protected]

Facility Contacts

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David Abramson, MD

Role: primary

Razia Ludin, MHA,BSc, CCRC

Role: primary

Other Identifiers

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1001

Identifier Type: -

Identifier Source: org_study_id