Clinical Trial: Silicone Gel to Improve Scar in Microtia Patients

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

Official Title: Use of Silicone Gel to Improve Retroauricular Scar in Microtia Patients

Brief Summary: Effort to reduce post-surgical scar is especially important for microtia patients. Even the scar lies posterior to ear auricle, but hypertrophic scar contracture may limit the ear auricle projection. If the scar is hypertrophic and conspicuous, this stigmata will accompanies the child for many years.The main objective aim of this study is to examine whether post-operative use of silicone gel can improve scar formation for microtia reconstruction scars.

Detailed Summary:

Background:

A scar represents dermal fibrous replacement tissue and results from a wound that has healed by resolution rather than regeneration. Undesirable scars, such as hypertrophic or keloid scars, occur most frequently over the anterior chest, shoulders, scapular area, lower abdomen and suprapubic region. Many of the investigators' microtia patients complained postsurgical hypertrophic scar. The incidence of hypertrophic scars after microtia reconstruction could be 6.29%.

Effort to reduce post-surgical scar is especially important for microtia patients. Even the scar lies posterior to ear auricle, but hypertrophic scar contracture may limit the ear auricle projection. If the scar is hypertrophic and conspicuous, this stigmata will accompanies the child for many years. The micropore tapes is very useful for facial scars. However, because of retroauricular contour and hairline, micropore tapes is difficult to retained over it place. Self-dry silicone gel is effective in both treatment and prevention of hypertrophic scar. It is consider first line for hypertrophic prevention in last update of facial scar care.

The main objective aim of this study is to examine whether post-operative use of silicone gel can improve scar formation for microtia reconstruction scars.

Patients and Methods:

This is a prospective randomize clinical trial primarily designed to compare the scarring after second stage of microtia repair with post-operative use of self-drying silicone gel. The control group did not use self-drying silicone gel for their scar care. The study group will receive application of self-dry silicone gel (Dermatix Ultra Gel - Invida, Hanson Medical Inc, USA) twice a day.

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Sponsor: Chang Gung Memorial Hospital

Current Primary Outcome: Scar width [ Time Frame: 6 months after surgery ]

6 months after surgery, the scar width will be measured


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Vancouver Scar Scale [ Time Frame: 6 months after surgery ]
    6 months after surgery, the scar quality will be assessed with Vancouver Scar
  • Visual Analogue Scale [ Time Frame: 6 months after surgery ]
    6 months after surgery, the scar will be assessed with visual analogue scale of 10 grade


Original Secondary Outcome: Same as current

Information By: Chang Gung Memorial Hospital

Dates:
Date Received: August 5, 2015
Date Started: July 2015
Date Completion: August 2018
Last Updated: August 6, 2015
Last Verified: July 2015