TerminatedNot Applicable

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

Stopped: PI left institution

United States24 participantsStarted 2020-09-21

Plain-language 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.

Who can participate

Age range6 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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)

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)

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)

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)

Trial details

NCT IDNCT04455035

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04-06

Results submitted2022-03-31

View on ClinicalTrials.gov More Cleft Lip and Palate trials