Impact of Dysport on PMFF Donor Scar

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT07720726
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abobotulinumtoxin-A — DRUG
    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
  • Control- Saline injection — OTHER
    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

Study Details

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.

Key Dates

First listed
Jul 22, 2026
Start date
Jul 1, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dysport Arm
    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 prior to paramedian forehead flap reconstruction of a nasal Mohs defect. Injection will occur in the operating room following anesthesia induction but prior to surgical prepping and draping.
  • Placebo Comparator: Placebo Arm
    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 prior to paramedian forehead flap reconstruction of a nasal Mohs defect. Injection will occur in the operating room following anesthesia induction but prior to surgical prepping and draping.

Primary Outcome Measure

Patient Observer Scar Assessment Scale (POSAS) [ Time Frame: POSAS scale will be administered at 1 week, 1 month, 3 months, 6 months, and 1 year post-operatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Nicole G DeSisto, MD
[email protected]
615-322-6180

Find similar trials in Nashville, TN

By condition
Skin cancerMelanoma
By specialty
OncologySkin cancerDermatology
By research site
Vanderbilt University Medical Center· Nashville, TN

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