Improvement of the Appearance of Cleft Lip Scars Using Botox
| Status: | Recruiting |
|---|---|
| Conditions: | Cosmetic, Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/24/2018 |
| Start Date: | December 2015 |
| End Date: | December 31, 2019 |
| Contact: | Jaecel O Shah, MD |
| Email: | jaecel.o.shah@uth.tmc.edu |
Botulinum Toxin to Improve Cosmesis of Primary Cleft Lip Repair
Objectives: To determine if the use of botulinum toxin during primary cleft lip repair
improves the cosmetic appearance of the scar
Study Design: Double blinded randomized controlled trial
Methods: Study to be completed at an academic tertiary hospital. Patients must be 6 months of
age or younger with a unrepaired complete unilateral cleft lip and palate requiring a primary
cheiloplasty. Botulinum toxin will be injected intraoperatively at 4 standardized sites in
the cleft lip during surgical repair. Control subjects will receive a placebo injection in
place of the toxin. Surgeons will be blinded to patients that receive the experimental
injection. Outcomes will be determined using 3D-videography preoperatively and post
operatively at scheduled visits with a total of one year follow up. A scar assessment
questionnaire will be completed by parents at select post operative visits. Videography
images will also be assessed by a blinded expert panel at the completion of the study.
improves the cosmetic appearance of the scar
Study Design: Double blinded randomized controlled trial
Methods: Study to be completed at an academic tertiary hospital. Patients must be 6 months of
age or younger with a unrepaired complete unilateral cleft lip and palate requiring a primary
cheiloplasty. Botulinum toxin will be injected intraoperatively at 4 standardized sites in
the cleft lip during surgical repair. Control subjects will receive a placebo injection in
place of the toxin. Surgeons will be blinded to patients that receive the experimental
injection. Outcomes will be determined using 3D-videography preoperatively and post
operatively at scheduled visits with a total of one year follow up. A scar assessment
questionnaire will be completed by parents at select post operative visits. Videography
images will also be assessed by a blinded expert panel at the completion of the study.
Inclusion Criteria:
Unilateral cleft lip with or without cleft palate, less than 6 months of age
Exclusion Criteria:
Bilateral cleft lip, older than 6 months of age
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