Scar Clinical Trial
Official title:
Use of Silicone Gel to Improve Retroauricular Scar in Microtia Patients
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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