Dysport for Forehead Scarring After Nasal Reconstruction
This study is looking at whether injections of Dysport (Abobotulinumtoxin-A), a common "Botox" type of medication, can improve the appearance and your satisfaction with a forehead scar. This scar happens after a paramedian forehead flap (PMFF) surgery, which is used to repair nasal defects from skin cancer removal (like basal cell carcinoma, squamous cell carcinoma, or melanoma). You would be randomly assigned to one of two groups: one receiving Dysport injections or one receiving saline (saltwater) injections at the forehead incision site during surgery. Researchers will measure how the scar looks and your satisfaction at various times up to one year after surgery. The study aims to enroll 50 adults aged 18 and older who need this type of nasal reconstruction.
- Study design
- This is a randomized study, meaning participants are randomly assigned to one of two groups. It plans to enroll 50 participants.
- What's involved
- You would receive an injection during surgery and have your scar assessed and satisfaction measured at 1 week, 1 month, 3 months, 6 months, and 1 year post-operatively.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for one year after their surgery to assess scar appearance and satisfaction.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Impact of Dysport on PMFF Donor Scar
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Shiayin F Yang, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Patient Observer Scar Assessment Scale (POSAS)POSAS scale will be administered at 1 week, 1 month, 3 months, 6 months, and 1 year post-operatively
Patient satisfaction with the appearance of the forehead donor site will be assessed at pre-determined time intervals using the Patient Observer Scar Assessment Scale (POSAS). This is a 7 question scale with all questions answered 1-10. Minimum final score value is 7 with maximum being 70. A higher score means a worse outcome.
- Patient Satisfaction Likert ScalePatient Satisfaction Likert scale will be administered at 1 week, 1 month, 3 months, 6 months, and 1 year post-operatively
Overall patient satisfaction with post-operative scar appearance will be evaluated with 5 separate Likert Scale questions ranked 1-10 with higher scores demonstrating a worse outcome.
- Vancouver Scar ScaleAssessed at 1 week, 1 month, 3 months, 6 months, and 1 year post-operatively
Appearance of Forehead Donor Site will be assessed at determined post-operative intervals by a blinded attending surgeon using the Vancouver Scar Scale (VSS). This scale includes four categories that assess scar characteristics. Final scores have a minimum value of 0 and a maximum value of 13 with a higher score demonstrating a worse outcome.
- Physician Graded Scar MetricsAssessed at 1 week, 1 month, 3 months, 6 months, and 1 year post-operatively
Appearance of Forehead Donor Site will be assessed at determined post-operative intervals by a blinded attending surgeon. Scar width (mm) as well as abnormal scar healing will be assessed and documented. Abnormal scar healing categories include none, hypertrophic scar, and keloid scar. No numeric values will be assigned to this scale.