Silicone Gel to Improve Scar in Microtia Patients

Chang Gung Medical Foundation

Status and phase: Unknown; Phase 4

Conditions: Microtia; Scar

Treatments: Drug: Silicone Gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02518035

103-2849B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 9 to 20 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

No silicone gel treatment after remove of stitches

Experimental

Experimental group

Description:

Silicone gel applied for twice per day

Treatment:

Drug: Silicone Gel