Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT04661969
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2020-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
"Outcomes of Surgical Removal of Foreign Body Granulomas"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015745', 'term': 'Granuloma, Foreign-Body'}, {'id': 'D001169', 'term': 'Arthritis, Experimental'}], 'ancestors': [{'id': 'D006099', 'term': 'Granuloma'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005549', 'term': 'Foreign-Body Reaction'}, {'id': 'D005547', 'term': 'Foreign Bodies'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-09', 'studyFirstSubmitDate': '2020-12-04', 'studyFirstSubmitQcDate': '2020-12-04', 'lastUpdatePostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications', 'timeFrame': '30 days', 'description': 'Describe if patients have or not postoperative complications'}], 'secondaryOutcomes': [{'measure': 'Reactivation of symptoms', 'timeFrame': '9 to 76 months', 'description': 'Relapse of symptoms or new local complications'}, {'measure': 'Time for reactivation of symptoms', 'timeFrame': '9 to 76 months', 'description': 'Account the number of months for reactivation of symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['disease-free', 'autoimmune/inflammatory syndrome induced by adjuvants (ASIA)', 'adjuvant disease'], 'conditions': ['Foreign Body Granuloma', 'Surgery', 'Complication']}, 'descriptionModule': {'briefSummary': 'Illicit subcutaneous injection of high-viscosity fluids for restoration and improvement of body contour is a growing trend all around the world. Many local and systemic complications have been described. Local complications include deformity at the site of injection, granulomas and several skin changes like erythema, induration, and plaques (well-circumscribed, elevated, superficial, solid lesion).\n\nThe investigator designed a single-center, cross-sectional, retrospective, consecutive case series study and evaluated 49 surgeries performed in 35 patients with the history of foreign substances injection for cosmetic purposes and developed local complications. Investigators divided 4 groups accordingly to localization of foreign substances (FS). Group 1) FS disseminated to both lower extremities and buttocks; group 2) FS isolated to buttocks with moderate to severe skin changes, Group 3) FS isolated to lower legs with mild skin changes and superficial ulcerations and 4) FS isolated to lower legs with moderate to severe skin changes and/or ulceration. The investigators treated all patients surgically, which consisted of isolate ultrasonic liposuction for extraction of the material from the affected region (group 1) In-bloc excision and primary closure (group 2), Resection plus Vacuum assisted closure (VAC) and split thickness skin graft (STSG) (group 3) and In-bloc excision and microsurgical reconstruction (group 4). Statistical analysis was performed to find relations between type of surgery with complications, reactivation of symptoms, time for reactivation and a disease-free survival test (kaplan meier) was done.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '24 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients previously injected with foreign substances (FS) such as polymers for cosmetic soft tissue augmentation and the diagnosis of ASIA presented with mild to severe skin changes and treated surgically from January 2014 to March 2020 all in a private practice setting (Hospital Angeles Pedregal, Mexico city, MEXICO) and treated all by plastic surgeon senior author (JLM)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of injection of foreign substances for cosmetic purposes\n* Develop symptoms of Autoimmune syndrome induced by adjuvants\n* Mild to severe skin changes\n\nExclusion Criteria:\n\n* Refuse to participate in the analysis'}, 'identificationModule': {'nctId': 'NCT04661969', 'briefTitle': '"Outcomes of Surgical Removal of Foreign Body Granulomas"', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Angeles del Pedregal'}, 'officialTitle': '"Outcomes of Surgical Removal of Foreign Body Granulomas Due to Polymer Injection for Cosmetic Purposes"', 'orgStudyIdInfo': {'id': 'Polymer removal'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Foreign Substance disseminated to both lower extremities and buttocks', 'interventionNames': ['Procedure: Surgery']}, {'label': '2', 'description': 'Foreign Substance isolated to buttocks with moderate to severe skin changes', 'interventionNames': ['Procedure: Surgery']}, {'label': '3', 'description': 'Foreign substance isolated to lower legs with mild skin changes and superficial ulcerations', 'interventionNames': ['Procedure: Surgery']}, {'label': '4', 'description': 'Foreign substance isolated to lower legs with moderate to severe skin changes and/or ulceration', 'interventionNames': ['Procedure: Surgery']}], 'interventions': [{'name': 'Surgery', 'type': 'PROCEDURE', 'description': '(group 1) In-bloc excision and primary closure (group 2), Resection plus Vacuum assisted closure (VAC) and split thickness skin graft (STSG) (group 3) and In-bloc excision and microsurgical reconstruction (group 4).', 'armGroupLabels': ['1', '2', '3', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01330', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Hospital Angeles Pedregal', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Share complications table, kaplan-meier test.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Angeles del Pedregal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Plastic and reconstructive surgeon staff, MBA, FACS', 'investigatorFullName': 'javier lopez', 'investigatorAffiliation': 'Hospital Angeles del Pedregal'}}}}