Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-27 @ 4:09 PM
Study NCT ID:
NCT01970761
Status:
COMPLETED
Last Update Posted:
2013-10-28
First Post:
2013-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Fat Graft Alleviate Scar Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-23', 'studyFirstSubmitDate': '2013-10-23', 'studyFirstSubmitQcDate': '2013-10-23', 'lastUpdatePostDateStruct': {'date': '2013-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': 'preoperatively and postoperatively after 1 week, 4 weeks, and 24 weeks.'}], 'secondaryOutcomes': [{'measure': 'Neuropathic Pain Symptom Inventory (NPSI)', 'timeFrame': 'preoperatively and postoperatively after 1 week, 4 weeks, and 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Scar']}, 'descriptionModule': {'briefSummary': 'Traumatic wounds inflict small- and large-fiber sensory nerve damage, causing neuropathic pain in scar tissue. Autologous fat grafting has been clinically shown to improve scar quality, but scantly study has explored its effects on pain. The aim of the study was to survey its effect on pain.', 'detailedDescription': 'Methods: From February 2008 and June 2013, a total of 36 patients received autologous fat grafting in scar areas. Patients who Douleur Neuropathique 4 Questions (scores \\>4/10) were enrolled this study. The Visual Analogue Scale (VAS), and Neuropathic Pain Symptom Inventory (NPSI) were used to evaluate pain preoperatively and postoperatively after 1 week, 4 weeks, and 24 weeks. The mechanism of trauma, duration of allodynia, fat graft volume, and total follow-up time were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients received autologous fat grafting in scar areas', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* February 2008 and June 2013, patients received autologous fat grafting in scar areas and also had pain over scar area before surgery\n\nExclusion Criteria:\n\n* patients refused to participate the study'}, 'identificationModule': {'nctId': 'NCT01970761', 'briefTitle': 'Autologous Fat Graft Alleviate Scar Pain', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Alleviation of Neuropathic Scar Pain With Autologous Fat Graft', 'orgStudyIdInfo': {'id': 'KMUH-IRB-20120246'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'scar, Fat Graft, Visual Analogue Scale', 'description': 'patients received autologous fat grafting in scar areas'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80708', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'shu-hung huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Plastic Surgery, Department of Surgery, Kaohsiung Medical University Hospital'}, {'name': 'Chung-Sheng Lai, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Plastic Surgery, Department of Surgery, Kaohsiung Medical University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}