Unilateral Cleft Repair in One Surgery With Pure Primary Healing

NCT04108416 | Completed

• 1 other identifier: PurePrimary
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Retrospective analysis of the current surgical method to repair unilateral cleft lip and palate malformations at our centre

Conditions

Cleft Lip and Palate

Keywords

cleft lip; cleft palate; cleft lip and palate; orofacial cleft

Outcome Measures

Primary Outcomes (1)

• Cleft size measurement

  Cleft size is measured before and after passive palatal plate therapy

  Measured on a model after birth and at surgery with 8 month of age

Secondary Outcomes (2)

• Wound healing

  1, 3 and 6 month after surgery

• Adverse events

  6 month

Interventions

Cleft lip and palate repair PROCEDURE

The intervention is the currently used cleft lip and palate repair technique at the University Hospital Basel and University Childrens Hospital Basel

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

newborn patients with complete unilateral cleft lip and palate treated at the University Hospital Basel in Switzerland

You may qualify if:

• newborn patients with complete unilateral cleft lip and palate

You may not qualify if:

• with associated syndrome
• previous lip/ palate repair
• previous presurgical orthopaedics other than passive palatal plate

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Universitätsspital Basel

Basel, 4310, Switzerland

Location

Related Publications (5)

• Aduss H, Pruzansky S. Width of cleft at level of the tuberosities in complete unilateral cleft lip and palate. Plast Reconstr Surg. 1968 Feb;41(2):113-23. doi: 10.1097/00006534-196802000-00003. No abstract available.

  PMID: 4873510 BACKGROUND

• Berkowitz S, Duncan R, Evans C, Friede H, Kuijpers-Jagtman AM, Prahl-Anderson B, Rosenstein S. Timing of cleft palate closure should be based on the ratio of the area of the cleft to that of the palatal segments and not on age alone. Plast Reconstr Surg. 2005 May;115(6):1483-99. doi: 10.1097/01.prs.0000161673.31770.23.

  PMID: 15861051 BACKGROUND

• Mueller AA, Zschokke I, Brand S, Hockenjos C, Zeilhofer HF, Schwenzer-Zimmerer K. One-stage cleft repair outcome at age 6- to 18-years -- a comparison to the Eurocleft study data. Br J Oral Maxillofac Surg. 2012 Dec;50(8):762-8. doi: 10.1016/j.bjoms.2012.02.002. Epub 2012 May 1.

  PMID: 22551772 BACKGROUND

• Brief J, Behle JH, Stellzig-Eisenhauer A, Hassfeld S. Precision of landmark positioning on digitized models from patients with cleft lip and palate. Cleft Palate Craniofac J. 2006 Mar;43(2):168-73. doi: 10.1597/04-106.1.

  PMID: 16526922 BACKGROUND

• Benitez BK, Brudnicki A, Surowiec Z, Singh RK, Nalabothu P, Schumann D, Mueller AA. Continuous circular closure in unilateral cleft lip and plate repair in one surgery. J Craniomaxillofac Surg. 2022 Jan;50(1):76-85. doi: 10.1016/j.jcms.2021.07.002. Epub 2021 Aug 3.

  PMID: 34896005 DERIVED

MeSH Terms

Conditions

Cleft Lip; Cleft Palate

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities

Study Officials

• Benitez Benito, MD DMD

  University of Basel and University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: January 1, 2014
• Primary Completion: December 31, 2018
• Study Completion: June 30, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)