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

NCT04735237 | Unknown DMC

• 1 other identifier: Omfs 3.3.8
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Unilateral Cleft Lip

Keywords

Cleft lip; Unilateral Cleft lip; Lip revision surgery; Secondary lip repair; Autogenous fat injection

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  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 Outcomes (2)

• 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

• Satisfaction of patient after lip injection (or lip revision surgery) as assessed by scores of a patient's satisfaction survey.

  After one year

Study Arms (2)

Autogenous fat injection

EXPERIMENTAL

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

Procedure: Autogenous fat injection

Surgical revision with orbicularis oris muscle reconstruction

ACTIVE COMPARATOR

Procedure: Surgical revision with orbicularis oris muscle reconstruction.

Interventions

Autogenous fat injection PROCEDURE

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).

Autogenous fat injection

Surgical revision with orbicularis oris muscle reconstruction. PROCEDURE

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.

Also known as: Secondary cleft lip revision surgery

Surgical revision with orbicularis oris muscle reconstruction

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (21)

• Rogers CR, Meara JG, Mulliken JB. The philtrum in cleft lip: review of anatomy and techniques for construction. J Craniofac Surg. 2014 Jan;25(1):9-13. doi: 10.1097/SCS.0b013e3182a2dce4.

  PMID: 24240763 BACKGROUND

• Cho BC, Baik BS. Formation of philtral column using vertical interdigitation of orbicularis oris muscle flaps in secondary cleft lip. Plast Reconstr Surg. 2000 Oct;106(5):980-6. doi: 10.1097/00006534-200010000-00003.

  PMID: 11039367 BACKGROUND

• Kim SW, Oh M, Park JL, Oh AK, Park CG. Functional reconstruction of the philtral ridge and dimple in the repaired cleft lip. J Craniofac Surg. 2007 Nov;18(6):1343-8. doi: 10.1097/scs.0b013e31814e07de.

  PMID: 17993879 BACKGROUND

• Fan Q, Li Y, Danning Z, Zhang B, Chen S, Wang J. "Three-unit" muscle reconstruction in secondary cleft lip repair. Cleft Palate Craniofac J. 2015 Jan;52(1):88-95. doi: 10.1597/13-048.

  PMID: 24443976 BACKGROUND

• Li L, Xie F, Ma T, Zhang Z. Reconstruction of Philtrum Using Partial Splitting and Folding of Orbicularis Oris Muscle in Secondary Unilateral Cleft Lip. Plast Reconstr Surg. 2015 Dec;136(6):1274-1278. doi: 10.1097/PRS.0000000000001795.

  PMID: 26595020 BACKGROUND

• Yin N, Song T, Wu J, Chen B, Ma H, Zhao Z, Wang Y, Li H, Wu D. Unilateral microform cleft lip repair: application of muscle tension line group theory. J Craniofac Surg. 2015 Mar;26(2):343-6. doi: 10.1097/SCS.0000000000001460.

  PMID: 25723667 BACKGROUND

• Naidoo S, Butow KW. Philtrum reconstruction in unilateral cleft lip repair. Int J Oral Maxillofac Surg. 2019 Jun;48(6):716-719. doi: 10.1016/j.ijom.2018.11.003. Epub 2018 Dec 7.

  PMID: 30501933 BACKGROUND

• Wei J, Deng N, Herrler T, Zhang Y, Li Q, Hua C, Dai C. Short term results of philtrum reconstruction with an orbicularis oris muscle flap in cleft patients. J Craniomaxillofac Surg. 2020 Jun;48(6):569-573. doi: 10.1016/j.jcms.2020.03.008. Epub 2020 Apr 7.

  PMID: 32340907 BACKGROUND

• Ma H, Zhang N, Yin N, Guo B. Application of a Layered Muscle Flap Technique for the Reconstruction of the Cupid's Bow and Vermilion in the Repair of Secondary Cleft Lip Deformities. J Craniofac Surg. 2019 Nov-Dec;30(8):e723-e727. doi: 10.1097/SCS.0000000000005714.

  PMID: 31261342 BACKGROUND

• Lim AA, Allam KA, Taneja R, Kawamoto HK. Constructing the philtral column in the secondary cleft lip deformity: utilizing the palmaris longus graft. Ann Plast Surg. 2013 Mar;70(3):296-300. doi: 10.1097/SAP.0b013e3182326ef3.

  PMID: 23038138 BACKGROUND

• Wang Y, Qi Z, Wang X. Dermis reconstruction and dermis fat graft through an intraoral incision: a new method to correct the furrowed philtral column deformity in lesser-form cleft lip. Cleft Palate Craniofac J. 2014 Mar;51(2):184-8. doi: 10.1597/12-076. Epub 2013 Jan 15.

  PMID: 23320841 BACKGROUND

• Nadjmi N, Amadori S, Van de Casteele E. Secondary Cleft Lip Reconstruction and the Use of Pedicled, Deepithelialized Scar Tissue. Plast Reconstr Surg Glob Open. 2016 Oct 25;4(10):e1061. doi: 10.1097/GOX.0000000000001061. eCollection 2016 Oct.

  PMID: 27826467 BACKGROUND

• Diepenbrock RM, Green JM 3rd. Autologous Fat Transfer for Maxillofacial Reconstruction. Atlas Oral Maxillofac Surg Clin North Am. 2018 Mar;26(1):59-68. doi: 10.1016/j.cxom.2017.11.002. Epub 2017 Dec 8. No abstract available.

  PMID: 29362072 BACKGROUND

• Jones CM, Mackay DR. Autologous Fat Grafting in Cleft Lip and Palate. J Craniofac Surg. 2019 May/Jun;30(3):686-691. doi: 10.1097/SCS.0000000000005205.

  PMID: 31048606 BACKGROUND

• Zheng D, Zhou J, Yu L, Zhang Y, Wang J. Autologous Fat Transplantation to Improve Lip Contour in Secondary Cleft Lip Deformity. J Craniofac Surg. 2020 Mar/Apr;31(2):343-346. doi: 10.1097/SCS.0000000000006071.

  PMID: 31856127 BACKGROUND

• Koonce SL, Grant DG, Cook J, Stelnicki EJ. Autologous Fat Grafting in the Treatment of Cleft Lip Volume Asymmetry. Ann Plast Surg. 2018 Jun;80(6S Suppl 6):S352-S355. doi: 10.1097/SAP.0000000000001348.

  PMID: 29401128 BACKGROUND

• Alighieri C, Bettens K, Roche N, Bruneel L, Van Lierde K. Lipofilling in patients with a cleft lip (and palate) - a pilot study assessing functional outcomes and patients' satisfaction with appearance. Int J Pediatr Otorhinolaryngol. 2020 Jan;128:109692. doi: 10.1016/j.ijporl.2019.109692. Epub 2019 Sep 20.

  PMID: 31568953 BACKGROUND

• Jones CM, Morrow BT, Albright WB, Long RE, Samson TD, Mackay DR. Structural Fat Grafting to Improve Reconstructive Outcomes in Secondary Cleft Lip Deformity. Cleft Palate Craniofac J. 2017 Jan;54(1):70-74. doi: 10.1597/15-197. Epub 2016 Jan 11.

  PMID: 26752128 BACKGROUND

• Chang FC, Wallace CG, Hsiao YC, Huang JJ, Liu CS, Chen ZC, Chen PK, Chen JP, Chen YR. Long-term comparison study of philtral ridge morphology with two different techniques of philtral reconstruction. Int J Oral Maxillofac Surg. 2020 Oct;49(10):1254-1259. doi: 10.1016/j.ijom.2020.01.015. Epub 2020 Jan 30.

  PMID: 32007356 BACKGROUND

• Chang CS, Wallace CG, Hsiao YC, Chang CJ, Chen PK. Botulinum toxin to improve results in cleft lip repair: a double-blinded, randomized, vehicle-controlled clinical trial. PLoS One. 2014 Dec 26;9(12):e115690. doi: 10.1371/journal.pone.0115690. eCollection 2014.

  PMID: 25541942 BACKGROUND

• Zhang WH, Chen YY, Liu JJ, Liao XH, Du YC, Gao Y. Application of ultrasound imaging of upper lip orbicularis oris muscle. Int J Clin Exp Med. 2015 Mar 15;8(3):3391-400. eCollection 2015.

  PMID: 26064229 BACKGROUND

MeSH Terms

Conditions

Cleft Lip

Interventions

Reoperation

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Hassan Abdel-Ghany, PhD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Shereen I Faris, MSc

CONTACT

(002)01222944297; shereen.ishak@dentistry.cu.edu.eg

Shereen I Faris, MSc

CONTACT

(002)01222944297; sherysac@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Researcher

Model Details: * 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.

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: February 3, 2021
• Study Start: October 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share