NCT04090970

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 26, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

December 17, 2019

Status Verified

December 1, 2019

Enrollment Period

6 months

First QC Date

September 13, 2019

Last Update Submit

December 13, 2019

Conditions

Mohs Surgery

Outcome Measures

Primary Outcomes (1)

  • Healing Time

    28 days

Interventions

BriagenDEVICE

Natural complex carbohydrate wound dressing for skin wounds

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient seeking treatment for wound created by Mohs skin excision

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dr. David Abramson

Englewood, New Jersey, 07631, United States

RECRUITING

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

RECRUITING

Central Study Contacts

Emily English, PhD

CONTACT

443-682-7740info@gemstonebio.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2019

First Posted

September 16, 2019

Study Start

August 26, 2019

Primary Completion

March 1, 2020

Study Completion

May 1, 2020

Last Updated

December 17, 2019

Record last verified: 2019-12

Locations

US(2)