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NOT YET RECRUITING
NCT07720726
PHASE4

Impact of Dysport on PMFF Donor Scar

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: The Impact of Pre-Operative Abobotulinumtoxin-A Injection on Paramedian Forehead Flap Donor Site Scar Aesthetics- A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-07-01

Completion Date

2029-06-30

Last Updated

2026-07-22

Healthy Volunteers

No

Interventions

DRUG

Abobotulinumtoxin-A

Participants in the treatment arm will receive an injection of a total of 30 units of Dysport (Abobotulinumtoxin-A) to the Frontalis muscle on each side of the planned incision

OTHER

Control- Saline injection

Participants in the control arm will receive an injection of a total of 30 units of saline to the Frontalis muscle on each side of the planned incision

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States