Silicone Gel to Improve Scar in Microtia Patients
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|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
|Condition or disease||Intervention/treatment||Phase|
|Microtia Scar||Drug: Silicone Gel||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Placebo Comparator: Control
No silicone gel treatment after remove of stitches
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
- Scar width [ Time Frame: 6 months after surgery ]6 months after surgery, the scar width will be measured
- 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
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
|Contact: Chun-Shin Chang, M.D.; M.S.||firstname.lastname@example.org|
|Contact: Zung-Chung Chen, M.D.||88633281200 ext email@example.com|
|Principal Investigator:||Zung-Chung Chen, M.D.||Chang Gung Memorial Hospital|