NCT02518035

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 7, 2015

Status Verified

July 1, 2015

Enrollment Period

3.1 years

First QC Date

August 5, 2015

Last Update Submit

August 6, 2015

Conditions

MicrotiaScar

Outcome Measures

Primary Outcomes (1)

  • Scar width

    6 months after surgery, the scar width will be measured

    6 months after surgery

Secondary Outcomes (2)

  • Vancouver Scar Scale

    6 months after surgery

  • Visual Analogue Scale

    6 months after surgery

Study Arms (2)

Control

PLACEBO COMPARATOR

No silicone gel treatment after remove of stitches

Experimental

EXPERIMENTAL

Silicone gel applied for twice per day

Drug: Silicone Gel

Interventions

Silicone GelDRUG

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

Also known as: Dermatix Ultra Gel
Experimental

Eligibility Criteria

Age9 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with microtia.
  • Written informed consent given by parent/guardian.

You may not qualify if:

  • Combined other craniofacial anomalies
  • Without permission of parent/guardian, without signed informed consent by parent/guardian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Chun Shin

Taoyuan District, 333, Taiwan

RECRUITING

Related Publications (5)

  • 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.

    PMID: 19116506BACKGROUND

  • 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.

    PMID: 15480018BACKGROUND

  • 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.

    PMID: 20009834BACKGROUND

  • 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.

    PMID: 25892285BACKGROUND

  • 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.

    PMID: 24572854BACKGROUND

MeSH Terms

Conditions

Congenital MicrotiaCicatrix

Interventions

Silicone Gels

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SiliconesSiloxanesOrganosilicon CompoundsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Zung-Chung Chen, M.D.

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Shin Chang, M.D.; M.S.

CONTACT

886975365538frankchang@cgmh.org.tw

Zung-Chung Chen, M.D.

CONTACT

88633281200nd2430@cgmh.org.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 7, 2015

Study Start

July 1, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 7, 2015

Record last verified: 2015-07

Locations

TW(1)