Collaborative, Comparative Study on Three-dimensional Cleft Lip and Palate Morphology Prior to One-stage Cleft Repair (Warsaw/Basel)

University Hospital, Basel, Switzerland1 site in 1 country40 target enrollmentDecember 7, 2020

ConditionsCleft Lip and Palate Cleft Palate Craniofacial Deformity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cleft Lip and Palate
Sponsor: University Hospital, Basel, Switzerland
Enrollment: 40
Locations: 1
Primary Endpoint: True Cleft Area in mm2 of Newborns With Cleft Lip and Palate at 8 Month of Age
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective observational cohort study of consecutive patients with cleft lip and palate deformity undergoing cleft repair at the Institute of Mother and Child in Warsaw. Cleft morphology will be captured with photo and intraoral camera before routine surgery at around 8 months. Furthermore, wound healing at 3 months postoperative will be assessed.

Registry

clinicaltrials.gov

Start Date

December 7, 2020

End Date

March 8, 2024

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University Hospital, Basel, Switzerland

Responsible Party

Principal Investigator

Benito Benitez

Principal Investigator

University Hospital, Basel, Switzerland

Eligibility Criteria

Inclusion Criteria

•patients with orofacial cleft, who undergo routine cleft repair

Exclusion Criteria

•missing datasets
•no signed consent for research

Outcomes

Primary Outcomes

True Cleft Area in mm2 of Newborns With Cleft Lip and Palate at 8 Month of Age

Time Frame: Capture of the cleft morphology with photo and intraoral camera before routine surgery at around 8 months.

True cleft area in mm2 will be measured at 8 month of age in newborns with cleft lip and palate.

Secondary Outcomes

Wound Healing (fistula yes or no) 3 Months After One-Stage Cleft Repair(At 3 months postoperative)
Correlation of Cleft Width in mm and Wound Healing after One-Stage Cleft Repair(At surgery and at 3 months postoperative)
Cleft Width and Height in mm of Newborns With Cleft Lip and Palate at 8 Month of Age(Capture of the cleft morphology with photo and intraoral camera before routine surgery at around 8 months.)