Use of the type A botulinum toxin in patients submitted to cheiloplasty to improve results in scarring in patients with nonsyndromic cleft lip and palate

  • David Felipe Navarro-BarquínEmail author
  • Edgard Efren Lozada-Hernández
  • Myriam Tejeda-Hernández
  • Gerardo Adrian DeLeon-Jasso
  • Freya Estefania Morales-Rescalvo
  • Eduardo Flores-González
  • Felipe Piña-Aviles
Experimental Study



Cleft lip, and its association with cleft palate, is the most common craniofacial malformation worldwide, having a high incidence in the Hispanic population, with 9.6 cases being reported per 10,000 newborns. The standard treatment is cheiloplasty with satisfying functional result. However, the presence of the hypertrophic scar constitutes the most frequent sequel, requiring, in some cases, a new surgery. Said scar often becomes a social stigma of this pathology.


Aim: To determine if the application of type A botulinum toxin prior to the surgery, improves the aesthetical results of the surgery evaluated by the Vancouver scale.

A randomized triple-blind clinical trial was performed that included all patients from 4 to 24 months of age, with unilateral or bilateral cleft lip and palate, without any history of prior surgery, at the HRAEB in Mexico. The surgery was performed by the same senior surgeon in both groups. Patients were randomized into two groups: a study group of 11 patients who received a type A Botulinum toxin injection at least 7 days before the surgery and a control group of 11 patients who received placebo. Both groups were evaluated by a different investigator, 3 and 6 months postoperatively using the Vancouver scale.


There was statistical significance in the width of the scar in millimeters, in the study group, of 2 mm (0–3) and in the control group of 4 mm with p value of < 0.001. There was also a difference in Vancouver scale, obtaining in the study group a mean of 2 points (IC 0–3) and in the control group one of 4 points (IC 0–6) with a p value of < 0–001. No side effects of the toxin were documented during the study and there were less surgical complications.


The use of type A botulinum toxin decreases the presence of a hypertrophic scar in patients with a cleft lip who undergo primary cheiloplasty; however, more studies with a larger number of patients are needed.

Level of evidence: level II, therapeutic study.


Cleft lip Botulinum toxin Cheiloplasty 


Compliance with ethical standards

Ethical statement

The clinical trial was approved by the hospital committee of ethics and clinical research, with the number CEI 00420170731. Informed consent was explained and provided to patient parent before the intervention and attached to its clinical file.

Conflict of interest

David Felipe Navarro-Barquín, Edgard Efren Lozada-Hernández, Myriam Tejeda-Hernández, Gerardo Adrian DeLeon-Jasso, Freya Estefania Morales-Rescalvo, Eduardo Flores-González, Felipe Piña-Aviles declare that there is no conflict of interest and have no ties with the pharmaceutical industry.

Funding information

The financial support for this research was offered by Hospital Regional de Alta Especialidad del Bajio that supplied the Botulinum toxin for the administration to the selected patients.

Patient consent

Patients provided written consent for the use of their images.


  1. 1.
    Canfield MA, Honein MA, Yuskiv N, Xing J, Mai CT, Collins JS, Devine O, Petrini J, Ramadhani TA, Hobbs CA, Kirby RS, for the National Birth Defects Prevention Network (2006) National estimates and race/ethnic-specific variation of selected birth defects in the United States, 1999-2001. Birth Defects Res A Clin Mol Teratol 76(11):747–756CrossRefGoogle Scholar
  2. 2.
    Trigos-Micoló I (2012) El tratamiento de labio y paladar hendidos.Un asunto de Conciencia en México. Cirugía Plástica 22(2):48–49Google Scholar
  3. 3.
    Tollefson TT, Sykes JM (2014) Unilateral cleft lip. In: Goudy SG, Tollefson TT (eds) Complete cleft care. Thieme, New York, pp 37–59Google Scholar
  4. 4.
    Sitzman TJ, Girotto JA, Marcus JR (2008) Current surgical practices in cleft care: unilateral cleft lip repair. Plast Reconstr Surg 121(5):261e–270eCrossRefGoogle Scholar
  5. 5.
    Sullivan T, Smith J, Kermode J, Mclver E, Courtemanche DJ (1990) Rating the burn scar. J Burn Care Rehabil 11:256–260CrossRefGoogle Scholar
  6. 6.
    Nedelec B, Shankowsky A, Tredgett EE (2000) Rating the resolving hypertrophic scar: comparison of Vancouver Scar Scale and scar volume. J Burn Care Rehabil 21:205–212CrossRefGoogle Scholar
  7. 7.
    Fearmonti R, Bond J, Erdmann D et al (2010) A review of scar scales and scar measuring devices. Eplasty 10:e43Google Scholar
  8. 8.
    Al-Ghatam R, Jones TE, Ireland AJ, Atack NE, Chawla O, Deacon S, Albery L, Cobb AR, Cadogan J, Leary S, Waylen A, Wills AK, Richard B, Bella H, Ness AR, Sandy JR (2015) Structural outcomes in the cleft care UK study. Part 2: dento-facial outcomes. Orthod Craniofac Res 18 Suppl 2:14–24CrossRefGoogle Scholar
  9. 9.
    Rosado D, Rico A (2001) Labio Leporino. Manual de cirugía plástica. Primera Edición. Ediciones SECPRE de la Sociedad Española de Cirugía plástica reparadora y Estética, EspañaGoogle Scholar
  10. 10.
    Waylen A, Ness AR, Wills AK (2015) Cleft care UK study. Part 5: child psychosocial outcomes and satisfaction with cleft services. Orthod Craniofac Res 18(Suppl. 2):47–55CrossRefGoogle Scholar
  11. 11.
    Young VL, Hutchison J (2009) Insights into patient and clinician concerns about scar appearance: semiquantitative structured surveys. Plast Reconstr Surg 124:256–265CrossRefGoogle Scholar
  12. 12.
    Tollefson TT, Senders CM, Sykes JM, Byorth PJ (2006) Botulinum toxin to improve results in cleft lip repair. Arch Facial Plast Surg 8:221–222CrossRefGoogle Scholar
  13. 13.
    Galárraga IM (2009) Use of botulinum toxin in cheiloplasty: a new method to decrease tension. Can J Plast Surg 17:e1–e2CrossRefGoogle Scholar
  14. 14.
    Hu L, Zou Y, Chang S-J, Qiu Y, Chen H, Gang M, Jin Y, Lin X (2018) Effects of botulinum toxin on improving facial surgical scars: a prospective, split-scar, double-blind, randomized controlled trial. Plast Reconstr Surg 141(3):646–650CrossRefGoogle Scholar
  15. 15.
    Chang C, Wallace G, Yen-Chang C, Chang CJ, Kuo-Ting P (2014) Botulinum toxin to improve results in cleft lip repair. Plast Reconstr Surg 134(3):511–516CrossRefGoogle Scholar
  16. 16.
    Haykal S, Arad E, Bagher S, Lai C, Hohman M, Hadlock T, Zuker RM, Borschel GH (2015) The Role of Botulinum Toxin A in the Establishment of Symmetry in Pediatric Paralysis of the Lower Lip. JAMA Facial Plast Surg 17(3):174–178CrossRefGoogle Scholar
  17. 17.
    Soltani AM, Francis CS, Motamed A, Karatsonyi AL, Hammoudeh JA, Sanchez-Lara PA, Reinisch JF, Urata MM (2012) Hypertrophic scarring in cleft lip repair: a comparison of incidence among ethnic groups. Clin Epidemiol 4:187–191PubMedPubMedCentralGoogle Scholar
  18. 18.
    Arno A, Gauglitz G, Barret J Up-to-date approach to manage keloids and hypertrophic scars: a useful guide, JBUR-4304; No. of Pages 12Google Scholar
  19. 19.
    Xiao Z, Zhang F, Lin W, Zhang M, Liu Y (2010) Effect of botulinum toxin type A on transforming growth factor beta1 in bro- blasts derived from hypertrophic scar: a preliminary report. Aesthet Plast Surg 34:424–427CrossRefGoogle Scholar
  20. 20.
    Carrillo-Córdova J, Martínez-Wagner R, Trolle-Silva, Bracho-Olvera H, Carrillo-Córdova, Carrillo-Córdova LD (2017) Botulinum toxin type A is associated with an increase in angiogenesis of wounds in an experimental murine model. Cirugía Plástica 27(3):107–112Google Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • David Felipe Navarro-Barquín
    • 1
    Email author
  • Edgard Efren Lozada-Hernández
    • 2
  • Myriam Tejeda-Hernández
    • 2
  • Gerardo Adrian DeLeon-Jasso
    • 2
  • Freya Estefania Morales-Rescalvo
    • 2
  • Eduardo Flores-González
    • 2
  • Felipe Piña-Aviles
    • 2
  1. 1.Division of Plastic and Reconstructive SurgeryHospital General “Dr. Manuel Gea González”Mexico CityMexico
  2. 2.Department of Plastic and Reconstructive SurgeryHospital Regional de Alta Especialidad del BajioLeónMexico

Personalised recommendations