Clinical trial · Interventional
Impact of Dysport on PMFF Donor Scar
The Impact of Pre-Operative Abobotulinumtoxin-A Injection on Paramedian Forehead Flap Donor Site Scar Aesthetics- A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Skin Cancer Excision Site | — | UNRESOLVED | — |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abobotulinumtoxin-A | Drug | — | UNRESOLVED |
| Control- Saline injection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dysport Arm
- description
- 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.
- interventionNames
- Drug: Abobotulinumtoxin-A
- type
- PLACEBO_COMPARATOR
- label
- Placebo Arm
- description
- 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.
- interventionNames
- Other: Control- Saline injection
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria Exclusion Criteria: * 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 * Allergy to cow's milk protein * Infection at proposed injection site * Previous scar or surgery at proposed injection site * Inability to follow-up in clinic * Inability to provide informed consent * Patient currently on aminoglycoside or other agent interfering with neuromuscular transmission * Patient on anticholinergic medication * Pregnancy
References
Publications (0)
Data not yet available