"BP as a New Device for Surgery and Solid Cancer and Hematopoietic System Tumors Treatment. Effects of BP Implantation"

NCT02328352 | Unknown Phase 1 DMC

• 1 other identifier: DM SALUTE 159/2010 20/09/2010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hernia of Abdominal Wall; Incisional Hernia

Keywords

Buckypaper (BP) of Multi-Walled Carbon Nanotubes (MWCNTs); surgical hernia prosthesis; abdominal wall defects surgery; prosthesis adhesion; disaster preparation and recovery hernia; Abdominal Wall Disaster Surgery; Fixation of prosthetic materials in general surgery

Outcome Measures

Primary Outcomes (1)

• number of moths without surgical hernia recurrence

  Durability (in months) without recurrence of hernia and incisional hernia of surgical device.

  54 weeks

Secondary Outcomes (3)

• number of mm displacement from the point of implantation (at 12 weeks after BP implantation)

  3 months

• number of BP fragments in bioptic samples of Bowman capsule

  12 weeks

• number of viable tumor cells in cultures after 48 hours of exposition to BP

  48 hours

Other Outcomes (1)

• delta of value of creatinine, transaminasis and PT, PTT, fibinogen from the T0 to 12 weeks.

  12 weeks

Study Arms (4)

BP selfstanding felt

EXPERIMENTAL

laparotomy intervention with the incision of 10 cm navel-pubis will be performed, splaying of the skin and subcutaneous layers, then will be incised the fascia plane, and muscles. Ten rabbits (hereafter defined as BPR1-BPR10) will receive 2x2cm2 samples of BP selfstanding felt in a pocket created between muscular fascia and large muscles of the abdominal wall. V-Loc 180 (ref VLOCL0024, lot. A1D0899)

Procedure: BP selfstanding felt

PP mesh

ACTIVE COMPARATOR

intervention of laparotomy with the incision of 10 cm navel-pubis will be performed, splaying of the skin and subcutaneous layers, then will be incised the fascia plane, and muscles. A 2x2cm2 sample of PP mesh was implanted without stitches into a pocket between large abdominal muscle and abdominal fascia. Other names: V-Loc 180 (ref VLOCL0024, lot. A1D0899) PR Parietene mesh Tyco (ref. PP3030, lot. SIK00587)

Procedure: PP mesh

BP intraperitoneal mesh

EXPERIMENTAL

A surgical scar was performed on the abdominal linea alba and carried out deeply for entering into the abdominal cavity. In five rabbits (BPR21-BPR25). A 2x2cm2 BP intraperitoneal mesh was then be inserted with the rough side facing the parietal peritoneum surface and the smooth and brilliant surface facing to the visceral peritoneum and gut.

Procedure: BP intraperitoneal mesh

control group

ACTIVE COMPARATOR

Five rabbits (R26-R30) will be used as control group.

Procedure: control group

Interventions

BP selfstanding felt PROCEDURE

intervention of laparotomy with the incision of 10 cm navel-pubis will be performed, splaying of the skin and subcutaneous layers, then will be incised the fascia plane, and muscles. Ten rabbits (hereafter defined as BPR1-BPR10) will receive 2x2cm2 samples of BP selfstanding felt in a pocket created between muscular fascia and large muscles of the abdominal wall.

Also known as: BP (Buckypaper NanoLab Inc., Newton, MA 02458 USA), V-Loc 180 (ref VLOCL0024, lot. A1D0899)

BP selfstanding felt

PP mesh PROCEDURE

intervention of laparotomy with the incision of 10 cm navel-pubis will be performed, splaying of the skin and subcutaneous layers, then will be incised the fascia plane, and muscles. A 2x2cm2 sample of PR (polypropylene) prosthesis was implanted without stitches into a pocket between large abdominal muscle and abdominal fascia

Also known as: Other names: V-Loc 180 (ref VLOCL0024, lot. A1D0899), PR Parietene mesh Tyco (ref. PP3030, lot. SIK00587)

PP mesh

BP intraperitoneal mesh PROCEDURE

Laparotomy on the linea alba carried out deeply for entering into the abdominal cavity, a 2x2cm2 BP sample implantation with the rough side facing the parietal peritoneum surface and the smooth and brilliant surface facing to the visceral peritoneum and gut

Also known as: BP (Buckypaper NanoLab Inc., Newton, MA 02458 USA), V-Loc 180 (ref VLOCL0024, lot. A1D0899)

BP intraperitoneal mesh

control group PROCEDURE

observational intervention in 5 rabbits with the same body weight and the same age will be observed and will be feeded in the same way of the BP device intraperitoneal implanted group

Also known as: famale 3000 gr New Zeeland rabbits (Harland)

control group

Eligibility Criteria

• Age: 3 Months - 6 Months
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• University of Sannio: collaborator
• Appialab Veterinary Reseach Labaratory: collaborator
• Catholic University of the Sacred Heart: collaborator
• Istituto Superiore di Sanità: collaborator

Study Sites (1)

National Health Institute (ISS Istituto Superiore di Sanità), Viale Regina Elena 299

Rome, Roma, 00161, Italy

Location

Related Publications (6)

• 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: 23635074 RESULT

• 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: 20148633 RESULT

• 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: 19572819 RESULT

• 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.

  PMID: 19063954 RESULT

• 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.

  PMID: 15362760 RESULT

• Catani M, De Milito R, Ratta 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. Italian.

  PMID: 10434461 RESULT

Related Links

• Carbon nanotubes toxicology and effects on metabolism and immunological modification in vitro and in vivo
• prot. C26A10HCNR, founding of 35000€ Prof Lucio D'Ilario, Prof. Andrea Martinelli, Dott. Massimo Chiaretti , prot letter 0003306 project n° 304P25, interfaculty Chemistry Dep, General Surgery Paride Stefanini Dep.

MeSH Terms

Conditions

Hernia, Abdominal; Incisional Hernia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Massimo Chiaretti, MD, PhD, MSc

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: December 31, 2014
• Study Start: October 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 31, 2014

Record last verified: 2014-12

Locations

IT (1)