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

The University of Texas System (UT)

Status: Terminated

Conditions: Cleft Lip and Palate

Treatments: Device: Prospective Group; Other: Comparator: Retrospective Group(Control)

Study type: Interventional

Funder types: Other

Identifiers

NCT04455035

HSC-DB-20-0311

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Retrospective Group(Control)

Active Comparator group

Treatment:

Other: Comparator: Retrospective Group(Control)

Prospective Group

Experimental group

Treatment:

Device: Prospective Group