Hernia Clinical Trial
— DM108/2008-BOfficial title:
"BP as a Super-light Mesh and as a New Fixing Device for General, Emergency and Prosthetic Surgery. The BP Implantation Effects on Immunity System, on the Metabolism and on Sealing. Preliminary Experimentation of Small Feasibility Study"
The Buckypaper (BP) is an innovative material that has attracted the attention of many research groups engaged in the study of its possible applications in various technological fields. Our purpose is demonstrate the viability of the application of nanotechnologies to the General Surgery in human with thwe use of a new self standing prosthetic device for the reconstruction of abdominal wall defects.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | December 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 2 Months to 4 Months |
Eligibility |
Inclusion Criteria: female Sprague Dawley rats of 300-500 grams of body weight Exclusion Criteria: - any kind of illness in rat subjects - out breed animals |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | National Health Institute (ISS Istituto Superiore di Sanità), Viale Regina Elena 299 | Rome | Roma |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza | Catholic University of the Sacred Heart, E D'Amore Istituto Superiore Sanità, P Consentino Appialab Veterinary Reseach Labaratory, University of Sannio |
Italy,
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. — View 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.09.10 — View Citation
Catani M, De Milito R, Spaziani E, Chiaretti M, Manili G, Capitano S, Di Filippo A, Simi M. [Laparoscopic inguinal hernia repair "IPOM" vs "open tension free". Preliminary results of a prospective randomized study]. Minerva Chir. 2003 Dec;58(6):783-9. Ita — View 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. — View 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | bio-adhesivity in mm | bio-adhesivity of the prosthetic material by the displacement in mm of the prosthesis from the implantation site | 5 weeks | Yes |
Primary | bio-compatibility by liver performance (by SGOT(Serum Glutamic Oxaloacetic Transaminase) | bio-compatibility of Buckypaper implanted in a lumbar scar by evaluation of liver function by SGOT(Serum Glutamic Oxaloacetic Transaminase), SGPT(Serum Glutamic PyruvateTransaminase), GGT(gamma glutamyl transferase), ALP(alkaline phosphatase) and fractionated bilirubin, PT(Prothrombin Time), APTT/PTT(Activated partial thromboplastin time), Fibrinogen. The evaluation will be performed at the beginning of experimentation and at the sacrifice after 35 days and will be evaluated the difference (delta) before and after implantation of BP | 5 weeks | Yes |
Secondary | cancer cell viability if exposed to BP | We will investigate the effects of exposition to BP fragments on healthy tissues and CaCo2 cells (Cancer Colon cluster), MCF-7 (Michigan Cancer Foundation-7), a breast cancer cell line, and hSCs (healthy smooth-muscle cells) of thyroid artery. | 5 weeks | Yes |
Secondary | bio-compatibility by kidney performance (by BUN and blood creatinine, and creatinine clearance) | bio-compatibility of Buckypaper implanted in a lumbar scar by evaluation of kidney by BUN and blood creatinine, and creatinine clearance. The evaluation will be performed at the beginning of experimentation and at the sacrifice after 35 days and will be evaluated the difference (delta) before and after implantation of BP | 5 weeks | Yes |
Secondary | bio-compatibility by marrow biologic performance (by CBC(Complete Blood Count) | bio-compatibility of Buckypaper implanted in a lumbar scar by evaluation of marrow function by CBC(Complete Blood Count) formula, lymphocyte subpopulations, C-reactive protein, erythrocyte sedimentation rate. The evaluation will be performed at the beginning of experimentation and at the sacrifice after 35 days and will be evaluated the difference (delta) before and after implantation of BP | 5 weeks | Yes |
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