A Phase 3 interventional study of Botulinum Toxin Type A and Botulinum Type A in Scar, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 3 Months to 45 Years. Per ClinicalTrials.gov, last updated 2011-09-07.
Sponsored by Chang Gung Memorial Hospital · Phase 3, Interventional, and Treatment
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.
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:-
Control group II: Similar amount (in C.C.) of normal saline will be injected after revision lip surgery (secondary cleft lip repair).
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 60 for secondary lip repair
4.31 Sample size calculation: 10 consecutive patient selected from our OPD on march 2009. Vancouver Scar Scale means 4.6 with SD 1.264911 (rage 3-7). If the study group with improvement of 1 is clinical significant, giving power 0.8 with the same SD, the sample size calculated will be 26.
Using Terason Ultrasound (capacity of measured 1/100 cm or 1/10 mm) the scar width mean is 1.13 mm with SD .6201254. If the study group with improvement of 0.5 mm as clinical significant, giving the power of 0.8 with the same SD, the sample size calculated will be 25.
We will use 30 patients for each group.
4.41 Exclusion criteria for primary lip repair
4.42 Exclusion criteria for the secondary lip repair
Without permission of parent/guardian, the patient signed the consent himself.
For control group a similar amount of Normal saline will be injected.
6.2 Follow-up Assessments 6.2.1 Vancouver scar scale (Sullivan T 1990) measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month F/U.
Ultrasonography measurement of the scar (Fong SS 1997)
For both primary and secondary lip surgery, the patient will receive postoperative follow up during 1wk, 1mo, 3mo, 6mo. On the 1st week postoperative follow up, the stitches will be removed, 3M taping will be placed over the wound to reduce surface tension and minimize the scar formation. On the 6th mo follow up, a lay person will assess the scar using the Vancouver scar and a plastic surgeon will use ultrasonography to measure the scar.
The Independent T-Student test will be used to analyze the statistical significance between the two groups.
Photographic measurement of scar 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.
162 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's planned enrollment of 120 is above the median of 30 across 114 interventional studies indexed under Cleft Lip.
Browse Cleft Lip studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for the primary lip repair group
Inclusion criteria for the secondary lip repair group
Exclusion Criteria:
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
Drug: Botulinum Toxin Type A
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.
Drug: Botulinum Type A
Similar amount as group I (in C.C.) of normal saline will be injected after primary lip surgery at 3 months of age.
Drug: Normal Saline
Similar amount (in C.C.) as Study Group II of normal saline will be injected after revision lip surgery (secondary cleft lip repair).
Drug: Normal Saline
1-2U/kg, at 25U/mL, into the bilateral aberrant oriented orbicularis ocuris muscle via 4 superficial injection site; only once after surgery. No additional injection is needed
Also known as: Botox ( Allergan, Inc., Irvine, Calif)
b. 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 just after surgery. (total dosage injected 15U)
Also known as: Botox ( Allergan, Inc., Irvine, Calif)
Similar amount (in C.C.) of normal saline as group I will be injected after primary lip surgery at 3 months of age.
Also known as: NaCl 0.9%
Similar amount (in C.C.) of normal saline as study group II will be injected after revision lip surgery (secondary cleft lip repair).
Also known as: NaCl 0.9%
Vancouver Scar scale
Vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month F/U.
Time frame: 6 month
Ultrasonography scar measurement
On the 6th mo follow up, ultrasonography to measure the scar width will be performed.
Time frame: 6 month
Photographic measurement
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.
Time frame: 6 month
This study is status unknown, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital