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Philtrum Reconstruction Using Autogenous Fat Injection Versus a Surgical Repair in Secondary Unilateral Cleft Lip Revision

NCT04735237 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-08-17

No results posted yet for this study

Summary

Two groups of patients with repaired unilateral cleft lip deformity having mild to moderate grooving and/or scarring of the philtral column and requiring a secondary cleft lip repair.

* The first group will receive upper lip fat injections into the philtral column (and other areas of volume insufficiency if needed) after manual fat liposuction from the abdomen.
* The second group will receive surgical lip revision with reconstruction of the orbicularis oris muscle using inverted horizontal mattress sutures for enhancement of the philtral ridge.

Conditions

  • Unilateral Cleft Lip

Interventions

PROCEDURE

Autogenous fat injection

Done under general anesthesia. Fat is to be harvested from the abdomen using manual liposuction. Small aliquots of fat are to be injected into the philtral column (and in the vermilion and any other area of volume insufficiency if needed).

PROCEDURE

Surgical revision with orbicularis oris muscle reconstruction.

Surgical repair done under general anesthesia. The original scar will be marked on the skin with methylene blue. The skin will be incised along the designed line with scar removal. The orbicularis oris muscle stump will be dissected medially and laterally and approximated by means of 4-0 inverted horizontal mattress sutures.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Hassan Abdel-Ghany, PhD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2022-11-30
Completion
2022-12-31

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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 NCT04735237 on ClinicalTrials.gov