Clinical trial NCT04455035: DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants
Official title: DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cleft Lip and Palate
Keywords: Dynacleft
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 24
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 infants who underwent DynaCleft® and that of their families.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in Soft Tissue as Indicated by Width of the Cleft Lip Measured From Extraoral Clinical Photographs
timeFrame: initial time of examination with study team, time of surgery (3 months post intervention)
measure: Changes in Soft Tissue as Indicated by Columellar Angle Measured From Extraoral Clinical Photographs
timeFrame: initial time of examination with study team, time of surgery (3 months post intervention)
measure: Changes in Soft Tissue as Indicated by Nostril Height Measured From Extraoral Clinical Photographs
timeFrame: initial time of examination with study team, time of surgery (3 months post intervention)
measure: Changes in Soft Tissue as Indicated by Nostril Width Measured From Extraoral Clinical Photographs
timeFrame: initial time of examination with study team, time of surgery (3 months post intervention)
Secondary outcomes:
measure: Average Number of Responses Indicating Improvement, no Change, or Decrease in Quality of Life as Assessed by the Infant and New Parent Quality of Life Questionnaire
timeFrame: initial time of examination with study team, time of surgery (3 months post intervention)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Brett T Chiquet, DDS
role: PRINCIPAL_INVESTIGATOR
References: