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Unilateral Cleft Lip Closure - Development of a New Hybrid Technique

NCT05102513 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-05-19

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Marco Kesting

    lead OTHER

Principal Investigators

  • Marco Kesting, Prof Dr Dr · Mund-, Kiefer- und Gesichtschirurgie Erlangen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
2 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2023-05-01
Completion
2023-11-01

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05102513 on ClinicalTrials.gov