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

August 15, 2021 updated by: Shereen Ishak Faris, Cairo University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 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).

  1. Same height as the normal side
  2. Less prominent than the normal side
  3. Flat philtral column
  4. Slight groove
  5. Prominent groove ( lesser scores mean better outcomes and higher scores mean worse outcomes)
preoperative, immediate postoperative, after one year.
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.
Time Frame: 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.
preoperative, immediate postoperative, after one year.
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.
Time Frame: 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.
preoperative, immediate postoperative, after one year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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).

  1. Significantly better than preoperative status
  2. No significant changes
  3. Widened scar ( lesser scores mean better outcomes and higher scores mean worse outcomes)
preoperative, immediate postoperative, after one year
Satisfaction of patient after lip injection (or lip revision surgery) as assessed by scores of a patient's satisfaction survey.
Time Frame: After one year
Patient's satisfaction survey (range: 0-20 points).
After one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Hassan Abdel-Ghany, PhD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 31, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 15, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Omfs 3.3.8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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