Unilateral Cleft Lip Closure - Development of a New Hybrid Technique

Marco Kesting

Status: Unknown

Conditions: Complete Unilateral Cleft Lip

Treatments: Procedure: Unilateral Cleft Lip Repair: Hybrid Technique; Procedure: Unilateral Cleft Lip Repair: Millard 2 Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT05102513

20211010

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 2 to 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Complete unilateral cleft lip and palate

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Unilateral Cleft Lip Repair with the New Hybrid Technique

Experimental group

Treatment:

Procedure: Unilateral Cleft Lip Repair: Hybrid Technique

Unilateral Cleft Lip Repair with the Millard II Technique

Active Comparator group

Treatment:

Procedure: Unilateral Cleft Lip Repair: Millard 2 Technique