Clinical trial NCT02137018: "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
Official title: "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".
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hernia
Incisional Hernia
Keywords: hernia
incisional hernia
device
pig
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
Collaborators: name: Martinelli, Andrea, M.D.
name: GA Carru
name: AM Chiaretti
name: F Faiola
name: G Ceccarelli
name: AI Chiaretti
name: P Consentino
name: E Valente
First posted: 2014-05-13
Enrollment: 30
Sex: FEMALE
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: "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.


Eligibility criteria: Inclusion Criteria:

* animal model: lantrace female pigs of 20 kg of body weight

Exclusion Criteria:

* any kind of illness in porcine subjects

Primary outcomes:
measure: Time of durability without side effects of surgical device
timeFrame: up to 36 months
Secondary outcomes:
measure: time required to position the device during surgery
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Animal House Agostino Gemelli University of Rome.
state: RM
Study officials:
affiliation: University of Roma La Sapienza
name: Massimo Chiaretti, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.