Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 11:35 PM
Study NCT ID:
NCT07269093
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy in Preventing Hypertrophic Scars: A Randomised Controlled Trial Comparing Chitosan Cream, Silicone Gel & Olive Oil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017439', 'term': 'Cicatrix, Hypertrophic'}], 'ancestors': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2025-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient and Observer Scar Assessment Scale (POSAS) scores', 'timeFrame': 'Enrolment to 24 weeks', 'description': "Each item is rated on a 5-point score. The lowest score is '1' which corresponds to the situation of normal skin. Score '5' being the largest difference from normal skin."}, {'measure': 'Scar Assessment and Rating (SCAR) Scale scores', 'timeFrame': 'Enrolment to 24 weeks', 'description': "Scores of clinical photographs of each scar by 3 plastic surgeons. Score '0' indicates conditions closest to normal skin. Maximum scores for each item range from 1 to 4, where higher scores indicate larger differences from normal skin."}], 'secondaryOutcomes': [{'measure': 'Side effects', 'timeFrame': 'Enrolment to 24 weeks', 'description': 'Patients are to report any side effects that they experience with use of any topical application. Side effects encountered are recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chitosan', 'silicone gel', 'olive oil', 'hypertrophic scars', 'prevention'], 'conditions': ['Hypertrophic Scars']}, 'referencesModule': {'references': [{'pmid': '27806156', 'type': 'BACKGROUND', 'citation': 'Kantor J. Reliability and Photographic Equivalency of the Scar Cosmesis Assessment and Rating (SCAR) Scale, an Outcome Measure for Postoperative Scars. JAMA Dermatol. 2017 Jan 1;153(1):55-60. doi: 10.1001/jamadermatol.2016.3757.'}, {'pmid': '36355319', 'type': 'BACKGROUND', 'citation': 'Carriere ME, Mokkink LB, Tyack Z, Westerman MJ, Pijpe A, Pleat J, van de Kar AL, Brown J, de Vet HCW, van Zuijlen PPM. Development of the Patient Scale of the Patient and Observer Scar Assessment Scale (POSAS) 3.0: a qualitative study. Qual Life Res. 2023 Feb;32(2):583-592. doi: 10.1007/s11136-022-03244-6. Epub 2022 Nov 10.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the efficacy of three different topical applications in preventing hypertrophic scars in adults with scars healed after suturing. The main question it aims to answer is: Is Chitosan cream effective in preventing hypertrophic scars?\n\nResearchers will compare Chitosan cream with silicone gel and olive oil to see if there is any difference in their efficacies.\n\nParticipants will be randomly assigned to three groups, with each group using a different topical application. They will be instructed to:\n\n* apply the topical application on their scar twice a day for 8 weeks\n* attend follow-up visits at 4, 12 and 24 weeks for a doctor to assess their scar and take clinical photographs\n* immediately inform the researcher if they experience any side effects', 'detailedDescription': 'This is a 3-arm single-blinded randomised controlled trial to study the efficacy of three topical applications in preventing hypertrophic scars. The general objective is to investigate the efficacy of Chitosan cream in preventing hypertrophic scars compared to other topical applications commonly used; silicone gel and olive oil. The hypothesis is that Chitosan cream shows comparable efficacy in preventing hypertrophic scars compared to silicone gel and olive oil.\n\nThe study population consists of patients who had traumatic or surgical scars that have healed by primary intention in the Unit of Reconstructive Sciences, Hospital Pakar USM, Plastic \\& Reconstructive Surgery Unit of Hospital Raja Perempuan Zainab II and the Plastic \\& Reconstructive Surgery Department of Hospital Kuala Lumpur and have met the study inclusion criteria.\n\nPatients who meet the inclusion criteria will be given a topical application (Chitosan cream / silicone gel / olive oil) which is assigned randomly by computer software (SPSS version 29). The topical applications is to be applied twice daily from the 14th day since wounding. The investigator will be blinded to the topical application given to the patient. Both patient and investigator will assess the scar using Patient \\& Observer Scar Assessment Scale (POSAS) version 3.0 and scars will be photographed under fixed camera settings \\& lighting conditions. Patients will come for follow-up on weeks 4, 12 \\& 24 and the scar assessment will be repeated by both patient \\& the same observer. Serial photographs will also be taken each visit. At the end of the 24 weeks, photographs of the scars will be reviewed by three independent plastic surgeons and scored using the Scar Cosmesis \\& Assessment Rating (SCAR) Scale. Both the scores from the clinical \\& photographic scar assessments will be evaluated to compare the efficacy of each topical application. The duration of the study is from Nov 2025-Nov 2026.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with traumatic or surgical wounds which have healed by primary intention within 14 days\n* Length of scar at least 3cm\n\nExclusion Criteria:\n\n* Patients with seafood allergy\n* Patients with scar from wounds that were complicated by infection or wound breakdown\n* Patients who have undergone scar treatment by other modalities\n* Patients with history of keloids / hypertrophic scars\n* Pregnant patients'}, 'identificationModule': {'nctId': 'NCT07269093', 'briefTitle': 'Efficacy in Preventing Hypertrophic Scars: A Randomised Controlled Trial Comparing Chitosan Cream, Silicone Gel & Olive Oil', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Sains Malaysia'}, 'officialTitle': 'Efficacy in Preventing Hypertrophic Scars: A Randomised Controlled Trial Comparing Chitosan Cream, Silicone Gel & Olive Oil', 'orgStudyIdInfo': {'id': 'USM/JEPeM/KK/25060539'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Silicone gel', 'description': 'Silicone gel application twice a day for 8 weeks', 'interventionNames': ['Device: Silicone Gel']}, {'type': 'EXPERIMENTAL', 'label': 'Chitosan cream', 'description': 'Chitosan cream application twice a day for 8 weeks', 'interventionNames': ['Device: Chitosan cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Olive oil', 'description': 'Olive oil application twice a day for 8 weeks', 'interventionNames': ['Device: Olive Oil Topical Oil']}], 'interventions': [{'name': 'Chitosan cream', 'type': 'DEVICE', 'description': 'Application of Chitosan cream twice daily for 8 weeks', 'armGroupLabels': ['Chitosan cream']}, {'name': 'Silicone Gel', 'type': 'DEVICE', 'description': 'Application of silicone gel twice a day for 8 weeks', 'armGroupLabels': ['Silicone gel']}, {'name': 'Olive Oil Topical Oil', 'type': 'DEVICE', 'description': 'Application of olive oil twice daily for 8 weeks', 'armGroupLabels': ['Olive oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15586', 'city': 'Kota Bharu', 'state': 'Kelantan', 'country': 'Malaysia', 'contacts': [{'name': 'Aida Nadhirah Nor Azizan, MBBS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Esther HM Tan, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Raja Perempuan Zainab II', 'geoPoint': {'lat': 6.12361, 'lon': 102.24333}}, {'zip': '16150', 'city': 'Kubang Kerian', 'state': 'Kelantan', 'country': 'Malaysia', 'contacts': [{'name': 'Esther HM Tan, MBBS', 'role': 'CONTACT', 'email': 'esthertan@student.usm.my', 'phone': '+6097673000'}, {'name': 'Esther HM Tan, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Amirul Akram Ahmad Sukari, MBBS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nor Aida Azizan, MBBS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ahmad Sukari Halim, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Pakar Universiti Sains Malaysia', 'geoPoint': {'lat': 6.09123, 'lon': 102.27938}}, {'zip': '50586', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'contacts': [{'name': 'Esther HM Tan, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Farah Hany Omar, MBBS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Kuala Lumpur', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'centralContacts': [{'name': 'Esther HM Tan, MBBS', 'role': 'CONTACT', 'email': 'esthertan@student.usm.my', 'phone': '+6097673000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Patient privacy protection'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Sains Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Esther Tan Hui Min', 'investigatorAffiliation': 'Universiti Sains Malaysia'}}}}