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Unilateral Cleft Lip Closure - Development of a New Hybrid Technique

Primary Purpose

Complete Unilateral Cleft Lip

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Unilateral Cleft Lip Repair: Hybrid Technique
Unilateral Cleft Lip Repair: Millard 2 Technique
Sponsored by
Marco Kesting
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complete Unilateral Cleft Lip focused on measuring Cleft Lip, Cleft Lip Repair, Unilateral Cleft Lip

Eligibility Criteria

2 Months - 12 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Complete unilateral cleft lip and palate

Exclusion Criteria:

-

Sites / Locations

  • Mund-, Kiefer- und Gesichtschirurgische KlinikRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Unilateral Cleft Lip Repair with the New Hybrid Technique

Unilateral Cleft Lip Repair with the Millard II Technique

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 19, 2021
Last Updated
May 18, 2022
Sponsor
Marco Kesting
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1. Study Identification

Unique Protocol Identification Number
NCT05102513
Brief Title
Unilateral Cleft Lip Closure - Development of a New Hybrid Technique
Official Title
Unilateral Cleft Lip Closure - Development of a New Hybrid Technique
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marco Kesting

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complete Unilateral Cleft Lip
Keywords
Cleft Lip, Cleft Lip Repair, Unilateral Cleft Lip

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
20 complete unilateral cleft lips are operated; 10 are treated with the Millard II technique and 10 are treated with the new hybrid technique
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unilateral Cleft Lip Repair with the New Hybrid Technique
Arm Type
Experimental
Arm Title
Unilateral Cleft Lip Repair with the Millard II Technique
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Unilateral Cleft Lip Repair: Hybrid Technique
Intervention Description
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
Intervention Name(s)
Unilateral Cleft Lip Repair: Millard 2 Technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement of the length of the philtral colomn on the cleft and non-cleft side
Description
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.
Time Frame
perioperatively to 6 month postoperatively
Title
Angle of the columella
Description
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.
Time Frame
perioperatively
Title
Distance from the midpoint of the columella to the lateral alae
Description
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.
Time Frame
perioperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Complete unilateral cleft lip and palate Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Kesting, Prof Dr Dr
Phone
+49 9131 8533601
Email
mkg-chirurgie@uk-erlangen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Buerstner
Phone
+491712740291
Email
jan.buerstner@fau.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Kesting, Prof Dr Dr
Organizational Affiliation
Mund-, Kiefer- und Gesichtschirurgie Erlangen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mund-, Kiefer- und Gesichtschirurgische Klinik
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Unilateral Cleft Lip Closure - Development of a New Hybrid Technique

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