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

Unilateral Cleft Lip Clinical Trial

Official title: Philtrum Reconstruction Using Autogenous Fat Injection Versus a Surgical Repair With Orbicularis Reconstruction, in Secondary Unilateral Cleft Lip Revision (A Randomized Clinical Trial)

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Interventions:

A. Intervention group: Fat injection

Harvesting fat from the donner site:

1. Surgical repair is to be done under general anesthesia.

2. IV infusion of cephalosporine antibiotic as surgical prophylaxis against infection

3. Tumescent fluid of normal saline and epinephrine 1:500,000 is to be hand infiltrated into the donor site (abdomen).

4. The lipoaspirate is to be harvested from the donor site using manual liposuction through a small incision (less than 0.5 cm). Fat is aspirated using a blunt tipped catheter on a 10-mL syringe.

5. The fat is emulsified.

Injecting fat into the lip:

1. The micro fat is reloaded into a 1-mL syringe and injected with a 1.5 mm blunt-tipped grafting needle.

2. Small aliquots of fat are injected into the philtral column.

3. Fat is to be injected in the vermilion and any other area of volume insufficiency if needed, depending on the contour of the lip.

B. Comparator group: Surgical revision with orbicularis oris muscle reconstruction.

1. Surgical repair is to be done under general anesthesia.

2. IV infusion of cephalosporine antibiotic as surgical prophylaxis against infection

3. The original scar will be marked on the skin with methylene blue.

4. The operating area will be injected with 0.5% lidocaine (containing 1:200,000 epinephrine).

5. The skin will be incised along the designed line with scar removal.

6. The orbicularis oris muscle stump is to be dissected medially and laterally.

7. In the medial segment, the dissection is restricted to within 5 mm medially to avoid crossing the center of the philtral dimple and to prevent any disruption of the normal philtral dimple. The muscle on the lateral cleft segment is to be freed from skin and mucosal by scissor dissection.

8. The medial and lateral orbicularis oris muscle stumps are approximated by means of 4-0 inverted horizontal mattress sutures. ;

Related Conditions & MeSH terms

• Cleft Lip
• Unilateral Cleft Lip

• NCT number: NCT04735237
• Study type: Interventional
• Source: Cairo University
• Contact: Shereen I Faris, MSc
• Phone: (002)01222944297
• Email: shereen.ishak@dentistry.cu.edu.eg
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2021
• Completion date: December 2022