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Silicone Gel to Improve Scar in Microtia Patients

Use of Silicone Gel to Improve Retroauricular Scar in Microtia Patients

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02518035
Enrollment
32
Registered
2015-08-07
Start date
2015-07-31
Completion date
2018-08-31
Last updated
2015-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microtia, Scar

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 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.

Interventions

Silicone gel will be applied twice per day in the experimental group

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
9 Years to 20 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Scar width6 months after surgery6 months after surgery, the scar width will be measured

Secondary

MeasureTime frameDescription
Vancouver Scar Scale6 months after surgery6 months after surgery, the scar quality will be assessed with Vancouver Scar
Visual Analogue Scale6 months after surgery6 months after surgery, the scar will be assessed with visual analogue scale of 10 grade

Countries

Taiwan

Contacts

Primary ContactChun-Shin Chang, M.D.; M.S.
frankchang@cgmh.org.tw886975365538
Backup ContactZung-Chung Chen, M.D.
nd2430@cgmh.org.tw88633281200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026