Philtrum Reconstruction Using Autogenous Fat Injection Versus a Surgical Repair in Secondary Unilateral Cleft Lip Revision
NCT ID: NCT04735237
Last Updated: 2021-08-17
Study Results
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Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-10-31
2022-12-31
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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.
TREATMENT
DOUBLE
Study Groups
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Autogenous fat injection
Fat will first be harvested from the abdomen, then injected into the lip
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).
Surgical revision with orbicularis oris muscle reconstruction
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.
Interventions
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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).
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Patients with any systemic disease that may affect normal healing.
3. Patients with any other craniofacial malformation.
4. Syndromic cleft patients.
4 Years
16 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Shereen Ishak Faris
Assistant Researcher
Principal Investigators
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Hassan Abdel-Ghany, PhD
Role: STUDY_DIRECTOR
Cairo University
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Omfs 3.3.8
Identifier Type: -
Identifier Source: org_study_id
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