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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04735237

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Unilateral Cleft Lip	Procedure: Autogenous fat injection Procedure: Surgical revision with orbicularis oris muscle reconstruction.	N/A

Detailed Description

Interventions:

Intervention group: Fat injection

Harvesting fat from the donner site:

Surgical repair is to be done under general anesthesia.
IV infusion of cephalosporine antibiotic as surgical prophylaxis against infection
Tumescent fluid of normal saline and epinephrine 1:500,000 is to be hand infiltrated into the donor site (abdomen).
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.
The fat is emulsified.

Injecting fat into the lip:

The micro fat is reloaded into a 1-mL syringe and injected with a 1.5 mm blunt-tipped grafting needle.
Small aliquots of fat are injected into the philtral column.
Fat is to be injected in the vermilion and any other area of volume insufficiency if needed, depending on the contour of the lip.

Comparator group: Surgical revision with orbicularis oris muscle reconstruction.

Surgical repair is to be done under general anesthesia.
IV infusion of cephalosporine antibiotic as surgical prophylaxis against infection
The original scar will be marked on the skin with methylene blue.
The operating area will be injected with 0.5% lidocaine (containing 1:200,000 epinephrine).
The skin will be incised along the designed line with scar removal.
The orbicularis oris muscle stump is to be dissected medially and laterally.
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.
The medial and lateral orbicularis oris muscle stumps are approximated by means of 4-0 inverted horizontal mattress sutures.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A randomized controlled clinical trial. The trial will be carried out in the clinic of Oral and Maxillofacial Surgery Department- Faculty of Dentistry-Cairo University & Pediatric Plastic Surgery Department (clinic & operative theatre), Cairo University. Equal randomization: participants with equal probabilities for randomization. Parallel group study: Each group of patient receives a single treatment simultaneously.A randomized controlled clinical trial. The trial will be carried out in the clinic of Oral and Maxillofacial Surgery Department- Faculty of Dentistry-Cairo University & Pediatric Plastic Surgery Department (clinic & operative theatre), Cairo University. Equal randomization: participants with equal probabilities for randomization. Parallel group study: Each group of patient receives a single treatment simultaneously.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Each patient will be given a code by the main researcher and the raters will be blind to which group this case belongs. Patients, raters and statistician will be blinded

Primary Purpose:

Treatment

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)

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Autogenous fat injection Fat will first be harvested from the abdomen, then injected into the lip	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).
Active Comparator: Surgical revision with orbicularis oris muscle reconstruction	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. Other Names: Secondary cleft lip revision surgery

Arm

Intervention/Treatment

Experimental: Autogenous fat injection

Fat will first be harvested from the abdomen, then injected into the lip

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).

Active Comparator: Surgical revision with orbicularis oris muscle reconstruction

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.

Other Names:

Secondary cleft lip revision surgery

Outcome Measures

Primary Outcome Measures

Efficacy of fat injection (or lip revision surgery) in philtral column enhancement assessed by measuring change in philtral column height using photographs and scores of a visual analogue sale (VAS). [preoperative, immediate postoperative, after one year.]
Change in philtral column height as assessed using photographs and scores of a visual analogue scale (scale described below). Same height as the normal side Less prominent than the normal side Flat philtral column Slight groove Prominent groove ( lesser scores mean better outcomes and higher scores mean worse outcomes)
Efficacy of fat injection (or lip revision surgery) in philtral column enhancement assessed by measuring change in philtral column projection in mm using a special device clinically. [preoperative, immediate postoperative, after one year.]
Change in philtral column projection as assessed clinically using a special device to obtain quantitative measurements of philtral column projection in mm.
Efficacy of fat injection (or lip revision surgery) in philtral column enhancement assessed by measuring change in height and projection of philtral column in mm using lip ultrasonography. [preoperative, immediate postoperative, after one year.]
Change in height and projection of philtral column as assessed using lip ultrasonography to obtain quantitative measurements of philtral column height and projection in mm.

Secondary Outcome Measures

Efficacy of fat injection (or lip revision surgery) in scar tissue modulation measured by assessing change in the appearance of the scar using photographs and scores of a VAS preoperatively, immediately postoperative and after one year. [preoperative, immediate postoperative, after one year]
Change in the appearance of the scar as assessed by photographs and scores of a three point visual analogue scale (scale described below). Significantly better than preoperative status No significant changes Widened scar ( lesser scores mean better outcomes and higher scores mean worse outcomes)
Satisfaction of patient after lip injection (or lip revision surgery) as assessed by scores of a patient's satisfaction survey. [After one year]
Patient's satisfaction survey (range: 0-20 points).

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients with repaired unilateral cleft lip deformity.
Mild to moderate grooving and/or scarring of the philtral column.
Patients who require a secondary cleft lip repair.
Age of the patient between 4 & 16 years
All patients are free from any systemic disease that may affect normal tissue healing.

Exclusion Criteria:

Patients older than 16 years old or whose caregivers declined a revisionary operation.
Patients with any systemic disease that may affect normal healing.
Patients with any other craniofacial malformation.
Syndromic cleft patients.