Silicone Gel to Improve Scar in Microtia Patients
Primary Purpose
Microtia, Scar
Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Silicone Gel
Sponsored by
About this trial
This is an interventional treatment trial for Microtia
Eligibility Criteria
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.
Sites / Locations
- Chang Chun ShinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Experimental
Arm Description
No silicone gel treatment after remove of stitches
Silicone gel applied for twice per day
Outcomes
Primary Outcome Measures
Scar width
6 months after surgery, the scar width will be measured
Secondary Outcome Measures
Vancouver Scar Scale
6 months after surgery, the scar quality will be assessed with Vancouver Scar
Visual Analogue Scale
6 months after surgery, the scar will be assessed with visual analogue scale of 10 grade
Full Information
NCT ID
NCT02518035
First Posted
August 5, 2015
Last Updated
August 6, 2015
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02518035
Brief Title
Silicone Gel to Improve Scar in Microtia Patients
Official Title
Use of Silicone Gel to Improve Retroauricular Scar in Microtia Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microtia, Scar
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
No silicone gel treatment after remove of stitches
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Silicone gel applied for twice per day
Intervention Type
Drug
Intervention Name(s)
Silicone Gel
Other Intervention Name(s)
Dermatix Ultra Gel
Intervention Description
Silicone gel will be applied twice per day in the experimental group
Primary Outcome Measure Information:
Title
Scar width
Description
6 months after surgery, the scar width will be measured
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Vancouver Scar Scale
Description
6 months after surgery, the scar quality will be assessed with Vancouver Scar
Time Frame
6 months after surgery
Title
Visual Analogue Scale
Description
6 months after surgery, the scar will be assessed with visual analogue scale of 10 grade
Time Frame
6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun-Shin Chang, M.D.; M.S.
Phone
886975365538
Email
frankchang@cgmh.org.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Zung-Chung Chen, M.D.
Phone
88633281200
Ext
2430
Email
nd2430@cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zung-Chung Chen, M.D.
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Chun Shin
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun Shin Chang, M.D.
Phone
886975365538
Email
frankchang@cgmh.org.tw
First Name & Middle Initial & Last Name & Degree
Zung-Chung Chen
Phone
88633181200
Ext
2430
Email
nd2430@cgmh.org.tw
12. IPD Sharing Statement
Citations:
PubMed Identifier
19116506
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. No abstract available.
Results Reference
background
PubMed Identifier
15480018
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. doi: 10.1097/01.sap.0000106434.69246.29.
Results Reference
background
PubMed Identifier
20009834
Citation
Chen ZC, Goh RCW, 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):1477-1485. doi: 10.1097/PRS.0b013e3181babaf9.
Results Reference
background
PubMed Identifier
25892285
Citation
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.
Results Reference
background
PubMed Identifier
24572854
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):640-651. doi: 10.1097/01.prs.0000438052.14011.0a.
Results Reference
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Silicone Gel to Improve Scar in Microtia Patients
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