Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-03-01 @ 3:52 PM
Study NCT ID:
NCT02137018
Status:
UNKNOWN
Last Update Posted:
2015-06-15
First Post:
2014-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Nanotechnologies Applied to General Surgery and Emergency Surgery: Buckypaper as a New Fixing Method for Prosthetic Materials for the Treatment of Hernia and Incisional Hernia in Laparotomy and Laparoscopic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D000069290', 'term': 'Incisional Hernia'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-12', 'studyFirstSubmitDate': '2014-05-06', 'studyFirstSubmitQcDate': '2014-05-09', 'lastUpdatePostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of durability without side effects of surgical device', 'timeFrame': 'up to 36 months', 'description': 'We are testing the time (months/year) of durability without side effects of a new fixing method for prosthetic materials for abdominal wall hernias and wall defects repairing on pig model'}], 'secondaryOutcomes': [{'measure': 'time required to position the device during surgery', 'timeFrame': 'up to 36 months', 'description': 'time required to position the device during surgery (time is related with probability of side effect during surgery)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hernia', 'incisional hernia', 'device', 'pig'], 'conditions': ['Hernia', 'Incisional Hernia']}, 'referencesModule': {'references': [{'pmid': '23635074', 'type': 'BACKGROUND', 'citation': "Martinelli A, Carru GA, D'Ilario L, Caprioli F, Chiaretti M, Crisante F, Francolini I, Piozzi A. Wet adhesion of buckypaper produced from oxidized multiwalled carbon nanotubes on soft animal tissue. ACS Appl Mater Interfaces. 2013 May 22;5(10):4340-9. doi: 10.1021/am400543s. Epub 2013 May 1."}, {'pmid': '20148633', 'type': 'BACKGROUND', 'citation': 'Bellucci S, Chiaretti M, Onorato P, Rossella F, Grandi MS, Galinetto P, Sacco I, Micciulla F. Micro-Raman study of the role of sterilization on carbon nanotubes for biomedical applications. Nanomedicine (Lond). 2010 Feb;5(2):209-15. doi: 10.2217/nnm.09.100.'}, {'pmid': '19572819', 'type': 'BACKGROUND', 'citation': 'Bellucci S, Chiaretti M, Cucina A, Carru GA, Chiaretti AI. Multiwalled carbon nanotube buckypaper: toxicology and biological effects in vitro and in vivo. Nanomedicine (Lond). 2009 Jul;4(5):531-40. doi: 10.2217/nnm.09.36.'}, {'pmid': '19063954', 'type': 'BACKGROUND', 'citation': 'Di Sotto A, Chiaretti M, Carru GA, Bellucci S, Mazzanti G. Multi-walled carbon nanotubes: Lack of mutagenic activity in the bacterial reverse mutation assay. Toxicol Lett. 2009 Feb 10;184(3):192-7. doi: 10.1016/j.toxlet.2008.11.007. Epub 2008 Nov 21.'}]}, 'descriptionModule': {'briefSummary': '"Nanotechnologies applied to General Surgery and Emergency Surgery: The Buckypaper as a new fixing method for prosthetic materials in the treatment of abdominal wall hernias, diaphragmatic hernias, diaphragmatic rupture, incisional hernia and abdominal wall disaster in laparotomy procedure and laparoscopic procedures". Experimentation on breed pig Lantrace ANIMAL MODEL.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '3 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* animal model: lantrace female pigs of 20 kg of body weight\n\nExclusion Criteria:\n\n* any kind of illness in porcine subjects'}, 'identificationModule': {'nctId': 'NCT02137018', 'acronym': '36P', 'briefTitle': '"Nanotechnologies Applied to General Surgery and Emergency Surgery: Buckypaper as a New Fixing Method for Prosthetic Materials for the Treatment of Hernia and Incisional Hernia in Laparotomy and Laparoscopic', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': '"Nanotechnologies Applied to General Surgery and Emergency Surgery: The Buckypaper as a New Fixing Method for Prosthetic Materials in the Treatment of Abdominal Wall Hernias, Diaphragmatic Hernias, Diaphragmatic Rupture, Incisional Hernia and Abdominal Wall Disaster in Laparotomy Procedure and Laparoscopic Procedures".', 'orgStudyIdInfo': {'id': '36Pa'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'laparotomy with PPL mesh implantation', 'description': 'control group: laparotomy with PPL mesh implantation (traditional method)', 'interventionNames': ['Device: PPL mesh']}, {'type': 'EXPERIMENTAL', 'label': 'laparotomy with PPL fixation by BP', 'description': 'laparotomic surgery with PPL mesh fixation by BP (new fixing method)', 'interventionNames': ['Device: PPL fixation by BP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'laparoscopy with PPL mesh implantation', 'description': 'control group: laparoscopy with PPL mesh implantation (traditional method)', 'interventionNames': ['Device: PPL mesh']}, {'type': 'EXPERIMENTAL', 'label': 'laparoscopy with PPL fixation by BP', 'description': 'laparoscopic surgery with PPL mesh fixation by BP (new fixing method)', 'interventionNames': ['Device: PPL fixation by BP']}], 'interventions': [{'name': 'PPL fixation by BP', 'type': 'DEVICE', 'otherNames': ['PPL Premilene mesh B Braun (ref. 1064435, lot. 112313)', 'PPL Parietene mesh Tyco (ref. PP3030, lot. SIK00587)', 'V-Loc 180 (ref. VLOCL0024, lot. A1D0998)', 'The BP (NanoLab Inc, Newton, MA 02458 USA)'], 'description': 'A surgical scar was performed on the abdominal linea alba and carried out deeply into a pocket between large abdominal muscle and abdominal fascia. A pocket was created between the two layers. 5cm PLL prosthesis was implanted and fixed by BP patch. The scar was sutured with absorbable stitches on subcutaneous incision and not absorbable stitches on the cutaneous layer.', 'armGroupLabels': ['laparoscopy with PPL fixation by BP', 'laparotomy with PPL fixation by BP']}, {'name': 'PPL mesh', 'type': 'DEVICE', 'otherNames': ['PPL Premilene mesh B Braun (ref. 1064435, lot. 112313)', 'PPL Parietene mesh Tyco (ref. PP3030, lot. SIK00587)', 'V-Loc 180 (ref. VLOCL0024, lot. A1D0998)'], 'description': 'A surgical scar was performed on the abdominal linea alba and carried out deeply into a pocket between large abdominal muscle and abdominal fascia. A pocket was created between the two layers. 5cm PLL prosthesis was implanted and fixed by absorbable stichtes. The scar was sutured with absorbable stitches on subcutaneous incision and not absorbable suture on the cutaneous layer.', 'armGroupLabels': ['laparoscopy with PPL mesh implantation', 'laparotomy with PPL mesh implantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'state': 'RM', 'country': 'Italy', 'facility': 'Animal House Agostino Gemelli University of Rome.', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Massimo Chiaretti, MD, PhD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Roma La Sapienza'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'collaborators': [{'name': 'Martinelli, Andrea, M.D.', 'class': 'INDIV'}, {'name': 'GA Carru', 'class': 'UNKNOWN'}, {'name': 'AM Chiaretti', 'class': 'UNKNOWN'}, {'name': 'F Faiola', 'class': 'UNKNOWN'}, {'name': 'G Ceccarelli', 'class': 'UNKNOWN'}, {'name': 'AI Chiaretti', 'class': 'UNKNOWN'}, {'name': 'P Consentino', 'class': 'UNKNOWN'}, {'name': 'E Valente', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Massimo Chiaretti', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}