Cleft Lip and Palate Clinical Trial
Official title:
DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants
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 infants who underwent DynaCleft® and that of their families.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | June 1, 2021 |
Est. primary completion date | February 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 6 Months |
Eligibility | Inclusion Criteria: 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 Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in soft tissue as indicated by columellar angle measured from extraoral clinical photographs | initial time of examination with study team, time of surgery(3 months post intervention) | ||
Primary | Changes in soft tissue as indicated by nostril width measured from extraoral clinical photographs | initial time of examination with study team, time of surgery(3 months post intervention) | ||
Primary | Changes in soft tissue as indicated by nostril height measured from extraoral clinical photographs | initial time of examination with study team, time of surgery(3 months post intervention) | ||
Primary | Changes in soft tissue as indicated by width of the cleft lip measured from extraoral clinical photographs | initial time of examination with study team, time of surgery(3 months post intervention) | ||
Secondary | Quality of life assessment utilizing an Infant and New Parent Quality of Life questionnaire | initial time of examination with study team | ||
Secondary | Quality of life assessment utilizing an Infant and New Parent Quality of Life questionnaire | time of surgery(3 months post intervention) |
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