"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

NCT02137018 | Unknown Phase 1 DMC

• 1 other identifier: 36Pa
• 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, diaphragmatic hernias, diaphragmatic rupture, incisional hernia and abdominal wall disaster in laparotomy procedure and laparoscopic procedures". Experimentation on breed pig Lantrace ANIMAL MODEL.

Conditions

Hernia; Incisional Hernia

Keywords

hernia; incisional hernia; device; pig

Outcome Measures

Primary Outcomes (1)

• Time of durability without side effects of surgical device

  We are testing the time (months/year) of durability without side effects of a new fixing method for prosthetic materials for abdominal wall hernias and wall defects repairing on pig model

  up to 36 months

Secondary Outcomes (1)

• time required to position the device during surgery

  up to 36 months

Study Arms (4)

laparotomy with PPL mesh implantation

ACTIVE COMPARATOR

control group: laparotomy with PPL mesh implantation (traditional method)

Device: PPL mesh

laparotomy with PPL fixation by BP

EXPERIMENTAL

laparotomic surgery with PPL mesh fixation by BP (new fixing method)

Device: PPL fixation by BP

laparoscopy with PPL mesh implantation

ACTIVE COMPARATOR

control group: laparoscopy with PPL mesh implantation (traditional method)

Device: PPL mesh

laparoscopy with PPL fixation by BP

EXPERIMENTAL

laparoscopic surgery with PPL mesh fixation by BP (new fixing method)

Device: PPL fixation by BP

Interventions

PPL fixation by BP DEVICE

A surgical scar was performed on the abdominal linea alba and carried out deeply into a pocket between large abdominal muscle and abdominal fascia. A pocket was created between the two layers. 5cm PLL prosthesis was implanted and fixed by BP patch. The scar was sutured with absorbable stitches on subcutaneous incision and not absorbable stitches on the cutaneous layer.

Also known as: PPL Premilene mesh B Braun (ref. 1064435, lot. 112313), PPL Parietene mesh Tyco (ref. PP3030, lot. SIK00587), V-Loc 180 (ref. VLOCL0024, lot. A1D0998), The BP (NanoLab Inc, Newton, MA 02458 USA)

laparoscopy with PPL fixation by BP; laparotomy with PPL fixation by BP

PPL mesh DEVICE

A surgical scar was performed on the abdominal linea alba and carried out deeply into a pocket between large abdominal muscle and abdominal fascia. A pocket was created between the two layers. 5cm PLL prosthesis was implanted and fixed by absorbable stichtes. The scar was sutured with absorbable stitches on subcutaneous incision and not absorbable suture on the cutaneous layer.

Also known as: PPL Premilene mesh B Braun (ref. 1064435, lot. 112313), PPL Parietene mesh Tyco (ref. PP3030, lot. SIK00587), V-Loc 180 (ref. VLOCL0024, lot. A1D0998)

laparoscopy with PPL mesh implantation; laparotomy with PPL mesh implantation

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• any kind of illness in porcine subjects

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Martinelli, Andrea, M.D.: collaborator
• GA Carru: collaborator
• AM Chiaretti: collaborator
• F Faiola: collaborator
• G Ceccarelli: collaborator
• AI Chiaretti: collaborator
• P Consentino: collaborator
• E Valente: collaborator

Study Sites (1)

Animal House Agostino Gemelli University of Rome.

Rome, RM, 00168, Italy

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Hernia; Incisional Hernia

Condition Hierarchy (Ancestors)

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

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: Researcher

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 13, 2014
• Study Start: March 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 15, 2015

Record last verified: 2014-05

Locations

IT (1)