BP as a Super-light Mesh and as a New Fixation Device for General Surgery -DM108/2008-B

NCT02341222 | Unknown Early Phase 1 DMC

• 1 other identifier: DM108/2008-B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hernia

Keywords

hernia prosthetic surgery; incisional hernia prosthesis; prosthesis mesh fixation; prosthesis mesh biocompatibility

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• cancer cell viability if exposed to BP

  5 weeks

• bio-compatibility by kidney performance (by BUN and blood creatinine, and creatinine clearance)

  5 weeks

• bio-compatibility by marrow biologic performance (by CBC(Complete Blood Count)

  5 weeks

Other Outcomes (1)

• bio-adhesivity in mm

  5 weeks

Study Arms (2)

BP self-standing felt device

EXPERIMENTAL

BP device will be implanted under fascia group-A, operated subjects. A lumbar 4-5 cm incision will be performed, splaying of the skin and subcutaneous layers, then will be incised the fascia plane, with a blunt dissection the fascia will be separated from muscles. Fifteen rats will receive 2x2cm2 samples of BP (Buckypaper) in a pocket created between muscular fascia and large muscles. The rough opaque surface will face the muscle surface and the smooth brilliant surface will face the lower muscular fascia surface, without fixation with stitches. Then the scar will be sutured with absorbable stitches on the fascia incision edge and not absorbable stitches on the skin.

Device: BP self-standing felt device

PR (parietene) mesh device

ACTIVE COMPARATOR

A lumbar 4-5 cm incision will be performed, splaying of the skin and subcutaneous layers, then will be incised the fascia plane, with a blunt dissection the fascia will be separated from muscles. Fifteen rats (hereafter defined as BPR16-BPR30) will receive 2x2cm2 samples of PP (polypropylene) in a pocket created between muscular fascia and large muscles. The polypropylene prosthesis will be fixed to the muscle with absorbable sutures surface and then the muscular fascia will be sutured over the prosthesis, with absorbable stitches on the fascia. Not absorbable stitches will be sutured on the skin.

Device: PR Parietene mesh device

Interventions

BP self-standing felt device DEVICE

BP device will be implanted under fascia group-A, operated subjects. A lumbar 4-5 cm incision will be performed, splaying of the skin and subcutaneous layers, then will be incised the fascia plane, with a blunt dissection the fascia will be separated from muscles. Fifteen rats will receive 2x2cm2 samples of BP (Buckypaper) in a pocket created between muscular fascia and large muscles. The rough opaque surface will face the muscle surface and the smooth brilliant surface will face the lower muscular fascia surface, without fixation with stitches. Then the scar will be sutured with absorbable stitches on the fascia incision edge and not absorbable stitches on the skin.

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

BP self-standing felt device

PR Parietene mesh device DEVICE

Fifteen rats (hereafter defined as BPR16-BPR30 B-group control subjects) will receive 2x2cm2 samples of PP (polypropylene) in a pocket created between muscular fascia and large muscles. A lumbar 4-5 cm incision will be performed, splaying of the skin and subcutaneous layers, then will be incised the fascia plane, with a blunt dissection the fascia will be separated from muscles. Fifteen rats (hereafter defined as BPR16-BPR30) will receive 2x2cm2 samples of PP (polypropylene) in a pocket created between muscular fascia and large muscles. The polypropylene prosthesis will be fixed to the muscle with absorbable sutures surface and then the muscular fascia will be sutured over the prosthesis, with absorbable stitches on the fascia. Not absorbable stitches will be sutured on the skin.

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

PR (parietene) mesh device

Eligibility Criteria

• Age: 2 Months - 4 Months
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• any kind of illness in rat subjects
• out breed animals

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• University of Sannio: collaborator
• P Consentino Appialab Veterinary Reseach Labaratory: collaborator
• Catholic University of the Sacred Heart: collaborator
• E D'Amore Istituto Superiore Sanità: collaborator

Study Sites (1)

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

Rome, Roma, 00161, Italy

Location

Related Publications (5)

• 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, 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. Italian.

  PMID: 14663405 RESULT

Related Links

• preliminary results, doi:10.1088/0953-8984/20/47/474203

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Massimo Chiaretti, MD, PhD, MSc

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early 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, PhD, MSc

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: January 19, 2015
• Study Start: January 1, 2008
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 19, 2015

Record last verified: 2014-07

Locations

IT (1)