Unilateral Cleft Lip Closure - Development of a New Hybrid Technique

Unilateral cleft lips can be treated with different incision techniques. According to a survey by the American Cleft Palate Association, the Millard II technique is currently used by the majority of US cleft surgeons. In this technique, a cleft-sided advancement flap is pivoted from the cleft side into the rotation flap of the non-cleft side, which serves, among other things, to lengthen the lip. However, the rotational component is often insufficient to sufficiently lengthen the lip on the cleft side. The result is a raised red lip, a shortened edge of the philtrum or a so-called pipe-hole deformity. In order to compensate for these "deficiencies", a triangular flap is currently being formed in the area of the white roll, which is intended to provide sufficient lengthening.

However, the scar of the triangular flaps runs exactly opposite to the aesthetic unit. In addition, it often provides a step formation within the white roll. Knowing the weaknesses of the previous techniques, a further development of the incision was made. The rotational flap of the Millard II technique was extended by extending the incision into the columella - similar to the well-known Mohler technique. The caudal part of the advancement flap of the Millard II technique was extended by a wave incision as known from the Pfeifer procedure.

Study Overview

• Status: Recruiting
• Conditions: Complete Unilateral Cleft Lip
• Intervention / Treatment: Procedure: Unilateral Cleft Lip Repair: Hybrid Technique; Procedure: Unilateral Cleft Lip Repair: Millard 2 Technique

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marco Kesting, Prof Dr Dr; Phone Number: +49 9131 8533601; Email: mkg-chirurgie@uk-erlangen.de
• Study Contact Backup: Name: Jan Buerstner; Phone Number: +491712740291; Email: jan.buerstner@fau.de

Study Locations

• Germany
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • Recruiting
      • Mund-, Kiefer- und Gesichtschirurgische Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 1 year (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Complete unilateral cleft lip and palate

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Unilateral Cleft Lip Repair with the New Hybrid Technique	Procedure: Unilateral Cleft Lip Repair: Hybrid Technique; The rotation flap of the Millard II technique was expanded by extending the incision into the columella - similar to the well-known Mohler technique. The caudal part of the advancement flap of the Millard II technique was lengthened by a wave cut as known from the Pfeiffer procedure. For the vermillion a Noordhoff plasty is applied.
ACTIVE_COMPARATOR: Unilateral Cleft Lip Repair with the Millard II Technique	Procedure: Unilateral Cleft Lip Repair: Millard 2 Technique; A curved incision is marked skirting the philtral ridge. If more length is required a back-cut incision can be performed. The C-flap is outlined by the incision just marked and the incision along red-white border up to the base of the columella. On the cleft side an advancement flap is designed. For the vermillion a Noordhoff plasty is applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the length of the philtral colomn on the cleft and non-cleft side	Perioperatively, a 3-D scan and photos are taken. Additional photos are also taken after the removal of the stitches, after 3 months and after 6 months. From these, the increase in length of the philtral column can be determined with 3D computer software and with a linear measurement of the photos.	perioperatively to 6 month postoperatively
Angle of the columella	A 3d scan and photos are made perioperatively. From this the angle of the columella can be determined with a 3D Computer software and with a linear measurement of the photos.	perioperatively
Distance from the midpoint of the columella to the lateral alae	Perioperatively, a 3-D scan and photos are taken. The distance can be measured with a 3D computer software and with a linear measurement of the photos.	perioperatively

Collaborators and Investigators

• Sponsor: Marco Kesting
• Investigators: Principal Investigator: Marco Kesting, Prof Dr Dr, Mund-, Kiefer- und Gesichtschirurgie Erlangen

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2022
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): November 1, 2023

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (ACTUAL): November 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Cleft Lip; Cleft Lip Repair; Unilateral Cleft Lip
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: 20211010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No