Incisional Hernia Clinical Trial
— DM159Official title:
The Buckypaper as a New Device in the Treatment of Some Solid Cancer and Hematopoietic System Tumors and as a New Fixing Device for Prosthetic Surgery. In Vivo Study on Effects of BP Implantation, Preliminary to Human Surgical Applications
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 in humans,
in laparotomic procedures and as a new device for the treatment of solid cancer and
hematopoietic system tumors.
The experimentation on this new material, preliminary conducted on breed female rabbit New
Zeeland, will be applicable to human, if the results in terms of toxicity and durability
will be comfortable.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 3 Months to 6 Months |
Eligibility |
Inclusion Criteria: animal model: New Zeeland female rabbits of 3000 gr of body weight - Exclusion Criteria: any kind of illness in rabbit subjects |
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 | Appialab Veterinary Reseach Labaratory, Catholic University of the Sacred Heart, Istituto Superiore di Sanità, 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, Pietroletti R, Chiaretti M, Spaziani E, Leardi S, Simi M. Is there a place for intraperitoneal onlay mesh repair (IPOM) of inguinal hernia among laparoscopic techniques? Hepatogastroenterology. 2004 Sep-Oct;51(59):1387-92. — View Citation
Catani M, De Milito R, Rattà G, Abati G, Chiaretti M, Rengo M. [Laparoscopy in an abdominal emergency: the diagnosis and therapy in 3 clinical cases of acute abdomen]. Ann Ital Chir. 1999 Mar-Apr;70(2):265-8; discussion 268-9. Review. Italian. — 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 | delta of value of creatinine, transaminasis and PT, PTT, fibinogen from the T0 to 12 weeks. | toxicology of BP measured as modifications of values (delta) of creatinine, transaminasis and PT, PTT, fibinogen in blood samples from the T0 to 12 weeks. | 12 weeks | Yes |
Primary | number of moths without surgical hernia recurrence | Durability (in months) without recurrence of hernia and incisional hernia of surgical device. | 54 weeks | Yes |
Secondary | number of mm displacement from the point of implantation (at 12 weeks after BP implantation) | Ability (number of mm displacement from the point of implantation at 12 weeks after BP implantation) of the BP as bio-adhesive tape for prosthetic materials to avoid displacement of implanted prosthesis. | 3 months | Yes |
Secondary | number of BP fragments in bioptic samples of Bowman capsule | toxicology of BP measured as number of BP fragments in bioptic samples of Bowman capsule of the nephron at 12 weeks | 12 weeks | Yes |
Secondary | number of viable tumor cells in cultures after 48 hours of exposition to BP | antineoplastic activity of BP device in the treatment of some solid cancer and hematopoietic system tumors: this item is measured ex vivo as the ability of BP to inhibit tumor cell replication (number of viable tumor cells in cultures after 48 hours of exposition to BP) | 48 hours | Yes |
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