Impact of Dysport on PMFF Donor Scar
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Abobotulinumtoxin-A
DrugParticipants 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 interventionParticipants 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
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Dysport ArmExperimental treatment 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient Observer Scar Assessment Scale (POSAS)
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.
Time frame
POSAS scale will be administered at 1 week, 1 month, 3 months, 6 months, and 1 year post-operatively2
Patient Satisfaction Likert Scale
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.
Time frame
Patient Satisfaction Likert scale will be administered at 1 week, 1 month, 3 months, 6 months, and 1 year post-operatively3
Vancouver Scar Scale
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.
Time frame
Assessed at 1 week, 1 month, 3 months, 6 months, and 1 year post-operatively4
Physician Graded Scar Metrics
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.
Time frame
Assessed at 1 week, 1 month, 3 months, 6 months, and 1 year post-operativelySecondary outcomes
1
Side Effects
Side effects following Dysport injections including but not limited to injection site reaction, nose and throat irritation, upper respiratory tract infection, sinus pain/pressure, muscle weakness (other than injected muscle), fatigue, headache, musculoskeletal pain, eyelid edema, eyelid ptosis, eyebrow ptosis, and nausea will be assessed for and collected at each post-operative visit.
Time frame
1 week, 1 month, 3 months, 6 months, 1 year2
Wound Healing Complications
Would healing complications including but not limited to donor site infection requiring antibiotics or return to OR, flap site infection requiring antibiotics or return to OR, flap failure requiring return to OR, hypertrophic scar, suture extrusion, and forehead incision dehiscence will be assessed for and collected at each post-operative visit.
Time frame
1 week, 1 month, 3 months, 6 months, 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vanderbilt University Medical Center
Lead sponsor
Galderma R&D
Collaborator
Source ClinicalTrials.gov
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