Silicone Gel to Improve Scar in Microtia Patients

Scar Clinical Trial

Official title:

Use of Silicone Gel to Improve Retroauricular Scar in Microtia Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02518035
• Other study ID #: 103-2849B
• Status: Recruiting
• Phase: Phase 4
• First received: August 5, 2015
• Last updated: August 6, 2015
• Start date: July 2015
• Est. completion date: August 2018

Study information

• Verified date: July 2015
• Source: Chang Gung Memorial Hospital
• Contact: Chun-Shin Chang, M.D.; M.S.
• Phone: 886975365538
• Email: frankchang[@]cgmh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 20 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Microtia
• Scar

Intervention

Drug:
• Silicone Gel
Silicone gel will be applied twice per day in the experimental group

Locations

Country	Name	City	State
Taiwan	Chang Chun Shin	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

Chen ZC, Albdour MN, Lizardo JA, Chen YA, Chen PK. Precision of three-dimensional stereo-photogrammetry (3dMD™) in anthropometry of the auricle and its application in microtia reconstruction. J Plast Reconstr Aesthet Surg. 2015 May;68(5):622-31. doi: 10.1016/j.bjps.2015.02.020. Epub 2015 Mar 9. — View Citation

Chen ZC, Chen K, Jo LJ, Nagata S. Satisfactory reconstruction with autologous costal cartilage graft in a geriatric microtia patient. Plast Reconstr Surg. 2009 Jan;123(1):1e-6e. doi: 10.1097/PRS.0b013e3181934660. — View Citation

Chen ZC, Chen PK, Hung KF, Lo LJ, Chen YR. Microtia reconstruction with adjuvant 3-dimensional template model. Ann Plast Surg. 2004 Sep;53(3):282-7. — View Citation

Chen ZC, Goh RC, Chen PK, Lo LJ, Wang SY, Nagata S. A new method for the second-stage auricular projection of the Nagata method: ultra-delicate split-thickness skin graft in continuity with full-thickness skin. Plast Reconstr Surg. 2009 Nov;124(5):1477-85. doi: 10.1097/PRS.0b013e3181babaf9. — View Citation

Wallace CG, Mao HY, Wang CJ, Chen YA, Chen PK, Chen ZC. Three-dimensional computed tomography reveals different donor-site deformities in adult and growing microtia patients despite total subperichondrial costal cartilage harvest and donor-site reconstruction. Plast Reconstr Surg. 2014 Mar;133(3):640-51. doi: 10.1097/01.prs.0000438052.14011.0a. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scar width	6 months after surgery, the scar width will be measured	6 months after surgery	No
Secondary	Vancouver Scar Scale	6 months after surgery, the scar quality will be assessed with Vancouver Scar	6 months after surgery	No
Secondary	Visual Analogue Scale	6 months after surgery, the scar will be assessed with visual analogue scale of 10 grade	6 months after surgery	No