Clinical Trial: Botulinum Toxin to Improve Lower Blepharoplasty Scar

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Botulinum Toxin to Improve Lower Blepharoplasty Scar

Brief Summary:

The combination of Botulinum toxin for crow feet (lateral part of orbicularis oculi muscle) and lower blaphaloplasty might have reduces the tension on the end of lower blaphaloplasty incision whereas the scar is more visible on patient.

The main aim of this trial is to investigate whether the injection of Botulinum toxin into the bilateral orbicularis oculi muscles could improve the appearance of the scar after lower blepharoplasty.


Detailed Summary:

The main aim of this double blind randomized trial is to examine whether immediate post-operative injection of botulinum toxin into lateral part of bilateral orbicularis oculis muscles (the injection technique of crow feet) can improve scar formation for lower blepharoplasty patients.

This is a double blind randomized controlled trial primarily designed to compare the scarring after secondary cleft lip repair with immediate post-operative botulinum toxin injection into the into bilateral lateral orbicularis oculi muscles in patients with lower blepharoplasty. There will be 2 main groups in this study:-

  1. Study group (Group I): Immediately after lower blepharoplasty surgery 3 injections of 2.5U of botulinum toxin over lateral part of orbicularis oculi muscle.
  2. Control group (Group II): There will be the same amount of normal saline injection after lower blepharoplasty.

Follow-up Assessments Vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month Follow Up.

Visual analogue scale They were asked to score the scars on the photographs using a standard visual analogue scale graded from 0 (worst possible scar) to 10 (best possible scar).

Photographic measurement:

A ruler will be placed just below the surgical scar. Using Photoshop CS5, the scar width can be measured.

Chi-square will be used to analyze the demographic data ( i.e. Gender) The Independent T-Student test will be used to analyze the statistical significance between the two groups.

to score the scars on the photographs using a standard visual analogue scale graded from 0 (worst possible scar) to 10 (best possible scar).



Original Primary Outcome:

  • Vancouver scar scale [ Time Frame: 6 months after surgery ]
    Use vancouver scar scale to access the scar of blepharoplasty
  • Visual analogue scale [ Time Frame: 6 months after surgery ]
    to score the scars on the photographs using a standard visual analogue scale graded from 0 (worst possible scar) to 10 (best possible scar).
  • Photographic measurement [ Time Frame: 6 months after surgery ]
    A ruler will be placed just below the surgical scar. Using Photoshop CS5, the scar width can be measured


Current Secondary Outcome:

  • Vancouver scar scale [ Time Frame: 6 months after surgery ]
    Use vancouver scar scale to access the scar of blepharoplasty
  • Photographic measurement [ Time Frame: 6 months after surgery ]
    A ruler will be placed just below the surgical scar. Using Photoshop CS5, the scar width can be measured


Original Secondary Outcome:

Information By: Chang Gung Memorial Hospital

Dates:
Date Received: May 26, 2016
Date Started: June 2016
Date Completion: June 2018
Last Updated: June 22, 2016
Last Verified: May 2016