DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants

Not Applicable

Terminated

• Conditions: Cleft Lip and Palate
• Interventions: Device: Prospective Group

• Registration Number: NCT04455035
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-26
• Study First Submitted QC: 2020-06-29
• Study First Posted: 2020-07-02
• Study Start: 2020-09-21
• Primary Completion: 2021-04-06
• Study Completion: 2021-04-06
• Results First Submitted: 2022-03-31
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Results First Posted: 2024-12-30
• Last Update Posted: 2024-12-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prospective Group	Prospective Group	-

Primary Outcome Measures

Name	Time	Method
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)	Width of the cleft lip was measured from extraoral clinical photographs. Data reported is width of cleft lip at 3 months minus width of cleft lip at time of initial examination.
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)	Columellar angle was measured from extraoral clinical photographs. Data reported is columellar angle at 3 months minus columellar angle at time of initial examination.
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)	Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome.
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)	Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome.

Secondary Outcome Measures

Name	Time	Method
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	initial time of examination with study team, time of surgery (3 months post intervention)	The Infant and New Parent Quality of Life questionnaire consists of 22 questions related to quality of life. For each question, it was determined whether the response at 3 months indicated an improvement, no change, or a decrease in quality of life relative to the response at the time of initial examination. The average number with an improvement in quality of life (averaged over all 22 questions), the average number who had no change in quality of life (averaged over all 22 questions), and the average number who had a decrease in quality of life (averaged over all 22 questions) are reported.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States