Unilateral Cleft Lip Closure - Development of a New Hybrid Technique

NCT ID: NCT05102513

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-11-01

Brief Summary

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.

Conditions

Complete Unilateral Cleft Lip

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Unilateral Cleft Lip Repair with the New Hybrid Technique

Group Type: EXPERIMENTAL

Unilateral Cleft Lip Repair: Hybrid Technique

Intervention Type: PROCEDURE

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.

Unilateral Cleft Lip Repair with the Millard II Technique

Group Type: ACTIVE_COMPARATOR

Unilateral Cleft Lip Repair: Millard 2 Technique

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Complete unilateral cleft lip and palate

Exclusion Criteria

-

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marco Kesting

OTHER

Sponsor Role: lead

Responsible Party

Marco Kesting

Prof. Dr. med. Dr. med. dent.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marco Kesting, Prof Dr Dr

Role: PRINCIPAL_INVESTIGATOR

Mund-, Kiefer- und Gesichtschirurgie Erlangen

Locations

Mund-, Kiefer- und Gesichtschirurgische Klinik

Erlangen, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Marco Kesting, Prof Dr Dr

Role: CONTACT

mkg-chirurgie@uk-erlangen.de

+49 9131 8533601

Jan Buerstner

Role: CONTACT

jan.buerstner@fau.de

+491712740291

Other Identifiers

20211010

Identifier Type: -

Identifier Source: org_study_id