The purpose of this study is to evaluate effectiveness of Granexin® gel in reducing scar formation in surgical incisional wounds.
Participants that meet screening criteria will be eligible for randomization providing all other criteria are met. Participants enrolled will receive study drug for 3 days. The participants will have an additional follow-up period to assess scarring of both Granexin® gel and Vehicle gel incisions through end of study at Month 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
184
Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.
Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.
Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.
Private Clinic- David Kulber
Los Angeles, California, United States
Pasadena Surgeons
Pasadena, California, United States
Universal Axon Clinical Research
Doral, Florida, United States
Change in scar severity at Month 12
Assessed using the Patient and Observer Scar Assessment Scale (POSAS). The POSAS has a rage from 6 to 60 with higher scores indicating worse outcomes. One scale will be used for each segment of the scar. The score from each segment will be combined into one score.
Time frame: Month 12
Change in scar severity at Month 6, Month 9 and Month 12
Assessed using the Scar Cosmesis Assessment and Rating (SCAR) Scale. The SCAR scale has a range of 0 (best possible scar) to 15 (worst possible scar).
Time frame: Month 6, Month 9 and Month 12
Change in scar severity at Month 9
Assessed using the Patient and Observer Scar Assessment Scale (POSAS). The POSAS has a range from 6 to 60 with higher scores indicating worse outcomes. One scale will be used for each segment of the scar. The score from each segment will be combined into one score.
Time frame: Month 9
Proportion of subjects with incision healing complications
Investigator's assessment of incision healing complications
Time frame: Day 1 to Month 12
Proportion of subjects with incision infection
Investigator's assessment of presence or absence of infection
Time frame: Day 1 to Month 12
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Miami Plastic Surgery
Miami, Florida, United States
Ibrahim H. Amjad, MD, PA
West Miami, Florida, United States
Northwestern University - Feinberg School of Medicine - Division of Plastic & Reconstructive Surgery
Chicago, Illinois, United States
Iowa Plastic Surgery
Davenport, Iowa, United States
Luxurgery
New York, New York, United States
Wake Forest Baptist Hospital - Plastic and Reconstructive Surgery
Winston-Salem, North Carolina, United States
Integrated Aesthetics
Spring, Texas, United States
...and 1 more locations