Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-03-05 @ 5:41 PM
Study NCT ID:
NCT02518035
Status:
UNKNOWN
Last Update Posted:
2015-08-07
First Post:
2015-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Silicone Gel to Improve Scar in Microtia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065817', 'term': 'Congenital Microtia'}, {'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020034', 'term': 'Silicone Gels'}], 'ancestors': [{'id': 'D012828', 'term': 'Silicones'}, {'id': 'D012833', 'term': 'Siloxanes'}, {'id': 'D017646', 'term': 'Organosilicon Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-06', 'studyFirstSubmitDate': '2015-08-05', 'studyFirstSubmitQcDate': '2015-08-06', 'lastUpdatePostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scar width', 'timeFrame': '6 months after surgery', 'description': '6 months after surgery, the scar width will be measured'}], 'secondaryOutcomes': [{'measure': 'Vancouver Scar Scale', 'timeFrame': '6 months after surgery', 'description': '6 months after surgery, the scar quality will be assessed with Vancouver Scar'}, {'measure': 'Visual Analogue Scale', 'timeFrame': '6 months after surgery', 'description': '6 months after surgery, the scar will be assessed with visual analogue scale of 10 grade'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Microtia', 'Scar']}, 'referencesModule': {'references': [{'pmid': '19116506', 'type': 'BACKGROUND', '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.'}, {'pmid': '15480018', 'type': 'BACKGROUND', '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.'}, {'pmid': '20009834', 'type': 'BACKGROUND', '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.'}, {'pmid': '25892285', 'type': 'BACKGROUND', '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.'}, {'pmid': '24572854', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Background:\n\nA 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%.\n\nEffort 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.\n\nThe main objective aim of this study is to examine whether post-operative use of silicone gel can improve scar formation for microtia reconstruction scars.\n\nPatients and Methods:\n\nThis 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.\n\nSix 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with microtia.\n* Written informed consent given by parent/guardian.\n\nExclusion Criteria:\n\n* Combined other craniofacial anomalies\n* Without permission of parent/guardian, without signed informed consent by parent/guardian.'}, 'identificationModule': {'nctId': 'NCT02518035', 'briefTitle': 'Silicone Gel to Improve Scar in Microtia Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Use of Silicone Gel to Improve Retroauricular Scar in Microtia Patients', 'orgStudyIdInfo': {'id': '103-2849B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'No silicone gel treatment after remove of stitches'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Silicone gel applied for twice per day', 'interventionNames': ['Drug: Silicone Gel']}], 'interventions': [{'name': 'Silicone Gel', 'type': 'DRUG', 'otherNames': ['Dermatix Ultra Gel'], 'description': 'Silicone gel will be applied twice per day in the experimental group', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan District', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chun Shin Chang, M.D.', 'role': 'CONTACT', 'email': 'frankchang@cgmh.org.tw', 'phone': '886975365538'}, {'name': 'Zung-Chung Chen', 'role': 'CONTACT', 'email': 'nd2430@cgmh.org.tw', 'phone': '88633181200', 'phoneExt': '2430'}], 'facility': 'Chang Chun Shin', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'centralContacts': [{'name': 'Chun-Shin Chang, M.D.; M.S.', 'role': 'CONTACT', 'email': 'frankchang@cgmh.org.tw', 'phone': '886975365538'}, {'name': 'Zung-Chung Chen, M.D.', 'role': 'CONTACT', 'email': 'nd2430@cgmh.org.tw', 'phone': '88633281200', 'phoneExt': '2430'}], 'overallOfficials': [{'name': 'Zung-Chung Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}