Clinical Trial: Botulinum Toxin to Improve Results in Cleft Lip Repair

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Botulinum Toxin to Improve Results in Cleft Lip Repair

Brief Summary: Botulinum toxin type A (Botox; Allergan, Inc., Irvine, Calif) is widely used for facial rejuvenation and many other medical indications. It induces chemodenervation through its action on the presynaptic neuron, preventing release of acetylcholine, which leads to functional denervation of striated muscle for 2 to 6 months after injection. The use of botulinum toxin injection to reduce the facial scar is logical because this could reduce the tensile distracting force of the upper lip caused by the orbicularis oris muscle pull. Tollefson has demonstrate that botulinum toxin injection has decrease lip tension after primary lip repair in 3 children at 3-6 months of age The main aim of this randomized trial is to compare whether post-operative peri-surgical-injection of botulinum toxin into bilateral orbicularis oris muscles can improve scar formation for both primary and secondary cleft lip surgery.

Detailed Summary:

This is a randomized controlled trial primarily designed to compare the scarring after primary and secondary cleft lip repair using post-operative botulinum toxin injection. There will be 4 main groups in this study:-

  1. Study group I: For primary lip surgery, immediately after primary lip repair will received botulinum toxin injection (1-2U/kg, at 25U/mL) into the bilateral aberrant oriented orbicularis ocuris muscle via 4 superficial injection site (Tollefson TT 2006).
  2. Study group II: For revision lip surgery, immediately after revision lip surgery 3 injection of 2.5U of botulinum toxin with a distance of 0.5 cm from each injection and operative wound are injected over both sides of upper lip in a adult on the operation room.
  3. Control group I : Similar amount (in C.C.) of normal saline will be injected after primary lip surgery at 3 months of age.

  4. Control group II: Similar amount (in C.C.) of normal saline will be injected after revision lip surgery (secondary cleft lip repair).

    4. ELIGIBILITY 4.1 Inclusion criteria for the primary lip repair group (i) Baby born with cleft lip who will receive primary lip repair at 3 months of age (iii) Written informed consent given by parent/guardian.

4.2 Inclusion criteria for the secondary lip repair group (i) Adult > 16 years old. (ii) Moderate to severe secondary cleft lip and/or nose deformity that warrants corrective surgery.

(iii) Written informed consent given by parent/guardian/patient.

4.3 Patient numbers: 60 for primary lip repair and 6
Sponsor: Chang Gung Memorial Hospital

Current Primary Outcome: Vancouver Scar scale [ Time Frame: 6 month ]

Vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month F/U.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Ultrasonography scar measurement [ Time Frame: 6 month ]
    On the 6th mo follow up, ultrasonography to measure the scar width will be performed.
  • Photographic measurement [ Time Frame: 6 month ]
    The scar width of the patient's picture at 6 month after surgery will be measured using photoshop CS3 extended. One ruler will be placed on the patient's lip before taken the photo. Then the scar width could be measured.


Original Secondary Outcome: Same as current

Information By: Chang Gung Memorial Hospital

Dates:
Date Received: September 4, 2011
Date Started: July 2000
Date Completion: August 2013
Last Updated: September 6, 2011
Last Verified: August 2011