About this trial
The purpose of this research study is to investigate the effect of pre-operative injections of Dysport (Abobotulinumtoxin-A, commonly known as "Botox") on the cosmetic appearance of and overall satisfaction with study participant's forehead scar following paramedian forehead flap reconstruction for a nasal skin cancer defect. Participating in this research involves study participants being randomly placed in one of two treatment groups. The first treatment group will have "Botox" injected at the site of the planned forehead incision once the study participant is in the operating room and asleep, but prior to the start of the operation. The second treatment group will have normal saline injected at the site of the planned forehead incision to act as a control group. The study participant will then undergo paramedian forehead flap reconstruction of the nasal defect in the standard fashion by a facial plastic and reconstructive surgeon. At all post-operative appointments, photographs will be taken of the study participant's forehead scar, and the study participant will be asked to complete two short surveys. These two surveys will take approximately 5 minutes total to complete. Study participants may choose to participate in this research study so that the investigators may learn more about the cosmetic benefit of "Botox" when it comes to scar prevention which could potentially help future patients having the same surgery.
Eligibility criteria
Qualifiers
Adults at least 18 years of age with a post-mohs micrographic surgery nasal defect requiring PMFF reconstruction in the operating room or clinic at our institution
No other facial plastic surgery procedure or skin cancer reconstruction performed simultaneously
Lack all the below
Disqualifiers
Documented allergy to Abobotulinumtoxin-A
Previous hypersensitivity to Abobotulinumtoxin-A
Hypersensitivity to any botulinum toxin product or excipients
Previous adverse reaction to any botulinum toxin product or excipients
Trial design
Treatments tested in this trial
- Abobotulinumtoxin-A
- Control- Saline injection
Treatment groups
Sponsors and collaborators
Vanderbilt University Medical Center
Lead sponsor
Galderma R&D
Collaborator