Status:
TERMINATED
DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Cleft Lip and Palate
Eligibility:
All Genders
Up to 6 years
Phase:
NA
Brief Summary
The purpose of this study is to examine the effectiveness of the DynaCleft® system on soft tissues of infants with unilateral incomplete cleft lip and to assess influences on quality of life for infan...
Eligibility Criteria
Inclusion
- Retrospective Group:
- Unilateral cleft lip with or without cleft palate
- Patients of a single surgeon (Matthew Greives, MD)
- Patients with complete photographs:
- After birth, first visit
- At cleft lip repair (3-4 months)
- Post-operative cleft repair (about 1 year of age)
- Prospective Group:
- Patients with incomplete unilateral cleft lip with or without cleft palate
- Patients of any surgeon
Exclusion
- Retrospective Group:
- Bilateral cleft lip or complete unilateral cleft lip
- Patients operated on by other primary surgeons
- Patients with incomplete photo records will be evaluated to determine if the patient should be excluded
- Prospective Group:
- Patients with bilateral cleft lip or complete unilateral cleft lip
- Patients whose parents refuse to consent to inclusion
- Patients with tape allergies to the adhesive of the DynaCleft®
- Patients with syndromic craniofacial conditions or Tessier type facial clefts
Key Trial Info
Start Date :
September 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04455035
Start Date
September 21 2020
End Date
April 6 2021
Last Update
December 30 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030