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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.
Interventions:
A. Intervention group: Fat injection
Harvesting fat from the donner site:
Injecting fat into the lip:
B. Comparator group: Surgical revision with orbicularis oris muscle reconstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autogenous fat injection | Experimental | Fat will first be harvested from the abdomen, then injected into the lip |
|
| Surgical revision with orbicularis oris muscle reconstruction | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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). | Change in philtral column height as assessed using photographs and scores of a visual analogue scale (scale described below).
| 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. |
| 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. | Change in the appearance of the scar as assessed by photographs and scores of a three point visual analogue scale (scale described below).
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shereen I Faris, MSc | Contact | (002)01222944297 | shereen.ishak@dentistry.cu.edu.eg | |
| Shereen I Faris, MSc | Contact | (002)01222944297 | sherysac@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hassan Abdel-Ghany, PhD | Cairo University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24240763 | Background | 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. | |
| 11039367 | 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. |
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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
| 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. |
|
|
| 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. | Patient's satisfaction survey (range: 0-20 points). | After one year |
| 17993879 | 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. |
| 24443976 | 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. |
| 26595020 | 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. |
| 25723667 | 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. |
| 30501933 | 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. |
| 32340907 | 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. |
| 31261342 | 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. |
| 23038138 | 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. |
| 23320841 | 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. |
| 27826467 | 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. |
| 29362072 | 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. |
| 31048606 | 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. |
| 31856127 | 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. |
| 29401128 | 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. |
| 31568953 | 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. |
| 26752128 | 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. |
| 32007356 | 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. |
| 25541942 | 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. |
| 26064229 | 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. |
| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D012086 | Reoperation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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