Botulinum Toxin to Improve Results in Cleft Lip Repair

September 6, 2011 updated by: Chang Gung Memorial Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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 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

  1. Combined other craniofacial anomalies
  2. Without permission of parent/guardian, without signed informed consent by parent/guardian.

4.42 Exclusion criteria for the secondary lip repair

  1. Less than 15 years old
  2. Mild secondary cleft lip and / or nose deformity that does not warrant corrective surgery.
  3. Without written informed consent.

  4. Without permission of parent/guardian, the patient signed the consent himself.

    5. Botulinum Toxin injection 5.1 For Study group I: Injections are placed into the orbicularis oris muscle 5 mm adjacent to the scar and the vermilion border on each side of the operative wound (A total of 3 injections per side making a total of 6 injections per patient). 1-2U/kg (total dosage for baby) and 2.5 U (adult ) of botulinum toxin (Botox; allergen, Inc., Irvine, Calif) will be used for each injection. A total dosage of 15 U (for adult) will be injected into each patient.

    For control group a similar amount of Normal saline will be injected.

    6. STUDY VISITS AND ASSESSMENTS 6.1 Registration and Randomization (i) Confirmation of eligibility (ii) Information Sheet (iii) Written informed consent (iv) Registration of baby and adult into study and randomization (v) Scheduling of patient for botox injection immediately after surgery.

    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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chun Shin Chang
        • Contact:
        • Principal Investigator:
          • Chun-Shin Chang, M.D.
        • Principal Investigator:
          • Philip Kuo Ting Chen, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Inclusion criteria for the primary lip repair group

  • Baby born with cleft lip who will receive primary lip repair at 3 months of age
  • Written informed consent given by parent/guardian.

Inclusion criteria for the secondary lip repair group

  • Adult > 16 years old.
  • Moderate to severe secondary cleft lip and/or nose deformity that warrants corrective surgery.
  • Written informed consent given by parent/guardian/patient.

Exclusion Criteria:

  • Those patient not fit inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Drug: Botulinum Toxin Type A
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
Other Names:
  • Botox ( Allergan, Inc., Irvine, Calif)
EXPERIMENTAL: 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.
Drug: Botulinum Type A
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)
Other Names:
  • Botox ( Allergan, Inc., Irvine, Calif)
PLACEBO_COMPARATOR: Control Group I
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.) of normal saline as group I will be injected after primary lip surgery at 3 months of age.
Other Names:
  • NaCl 0.9%
Drug: Normal Saline
Similar amount (in C.C.) of normal saline as study group II will be injected after revision lip surgery (secondary cleft lip repair).
Other Names:
  • NaCl 0.9%
PLACEBO_COMPARATOR: Control II
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
Similar amount (in C.C.) of normal saline as group I will be injected after primary lip surgery at 3 months of age.
Other Names:
  • NaCl 0.9%
Drug: Normal Saline
Similar amount (in C.C.) of normal saline as study group II will be injected after revision lip surgery (secondary cleft lip repair).
Other Names:
  • NaCl 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vancouver Scar scale
Time Frame: 6 month
Vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month F/U.
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasonography scar measurement
Time Frame: 6 month
On the 6th mo follow up, ultrasonography to measure the scar width will be performed.
6 month
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.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Chun-Shin Chang, M.D., Chang Gung memorial hospital
  • Principal Investigator: Philip Kuo-Ting Chen, M.D., Chang Gung memorial hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ANTICIPATED)

August 1, 2013

Study Registration Dates

First Submitted

September 4, 2011

First Submitted That Met QC Criteria

September 6, 2011

First Posted (ESTIMATE)

September 7, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 7, 2011

Last Update Submitted That Met QC Criteria

September 6, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-2237C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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