Purpose

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.

Conditions

Eligibility

Eligible Ages
Under 6 Months
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Botulinum Toxin
Injection of botulinum toxin into cleft lip at time of surgical repair.
  • Drug: Botulinum Toxin Type A
    Injection of toxin at the time of surgery at cleft lip repair site
Placebo Comparator
Saline
Injection of normal saline into cleft lip at time of surgical repair.
  • Drug: Normal Saline Injection
    Injection of normal saline into cleft lip at time of surgical repair.

Recruiting Locations

Memorial Hermann Hospital
Houston, Texas 77030
Contact:
Carol Underwood, BSN/RN
713-704-4230

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Matthew R Greives, MD
(713) 500-7275
Matthew.R.Greives@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.