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Silicone Gel to Improve Scar in Microtia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02518035
Recruitment Status : Unknown
Verified July 2015 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : August 7, 2015
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Microtia Scar Drug: Silicone Gel Phase 4

Detailed Description:

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.

Six months after surgery, Vancouver scar sale and Visual analogue scale will be used for subjective scar measurement. Standard craniofacial photograph will be taken at the same time. A surgical ruler will be placed underneath the op wound. The scar width will be measured using with commercial software.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Silicone Gel to Improve Retroauricular Scar in Microtia Patients
Study Start Date : July 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Placebo Comparator: Control
No silicone gel treatment after remove of stitches
Experimental: Experimental
Silicone gel applied for twice per day
Drug: Silicone Gel
Silicone gel will be applied twice per day in the experimental group
Other Name: Dermatix Ultra Gel




Primary Outcome Measures :
  1. Scar width [ Time Frame: 6 months after surgery ]
    6 months after surgery, the scar width will be measured


Secondary Outcome Measures :
  1. Vancouver Scar Scale [ Time Frame: 6 months after surgery ]
    6 months after surgery, the scar quality will be assessed with Vancouver Scar

  2. 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



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Ages Eligible for Study:   9 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with microtia.
  • Written informed consent given by parent/guardian.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518035


Contacts
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Contact: Chun-Shin Chang, M.D.; M.S. 886975365538 frankchang@cgmh.org.tw
Contact: Zung-Chung Chen, M.D. 88633281200 ext 2430 nd2430@cgmh.org.tw

Locations
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Taiwan
Chang Chun Shin Recruiting
Taoyuan, Taiwan, 333
Contact: Chun Shin Chang, M.D.    886975365538    frankchang@cgmh.org.tw   
Contact: Zung-Chung Chen    88633181200 ext 2430    nd2430@cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Zung-Chung Chen, M.D. Chang Gung Memorial Hospital

Publications:
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02518035    
Other Study ID Numbers: 103-2849B
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Congenital Microtia
Ear Diseases
Otorhinolaryngologic Diseases
Congenital Abnormalities