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"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 (36P)

Primary Purpose

Hernia, Incisional Hernia

Status
Unknown status
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
PPL fixation by BP
PPL mesh
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia focused on measuring hernia, incisional hernia, device, pig

Eligibility Criteria

3 Months - 6 Months (Child)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • any kind of illness in porcine subjects

Sites / Locations

  • Animal House Agostino Gemelli University of Rome.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

laparotomy with PPL mesh implantation

laparotomy with PPL fixation by BP

laparoscopy with PPL mesh implantation

laparoscopy with PPL fixation by BP

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

time required to position the device during surgery
time required to position the device during surgery (time is related with probability of side effect during surgery)

Full Information

First Posted
May 6, 2014
Last Updated
June 12, 2015
Sponsor
University of Roma La Sapienza
Collaborators
Martinelli, Andrea, M.D., GA Carru, AM Chiaretti, F Faiola, G Ceccarelli, AI Chiaretti, P Consentino, E Valente
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1. Study Identification

Unique Protocol Identification Number
NCT02137018
Brief Title
"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
Acronym
36P
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
Collaborators
Martinelli, Andrea, M.D., GA Carru, AM Chiaretti, F Faiola, G Ceccarelli, AI Chiaretti, P Consentino, E Valente

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Incisional Hernia
Keywords
hernia, incisional hernia, device, pig

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laparotomy with PPL mesh implantation
Arm Type
Active Comparator
Arm Description
control group: laparotomy with PPL mesh implantation (traditional method)
Arm Title
laparotomy with PPL fixation by BP
Arm Type
Experimental
Arm Description
laparotomic surgery with PPL mesh fixation by BP (new fixing method)
Arm Title
laparoscopy with PPL mesh implantation
Arm Type
Active Comparator
Arm Description
control group: laparoscopy with PPL mesh implantation (traditional method)
Arm Title
laparoscopy with PPL fixation by BP
Arm Type
Experimental
Arm Description
laparoscopic surgery with PPL mesh fixation by BP (new fixing method)
Intervention Type
Device
Intervention Name(s)
PPL fixation by BP
Other Intervention Name(s)
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)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PPL mesh
Other Intervention Name(s)
PPL Premilene mesh B Braun (ref. 1064435, lot. 112313), PPL Parietene mesh Tyco (ref. PP3030, lot. SIK00587), V-Loc 180 (ref. VLOCL0024, lot. A1D0998)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time of durability without side effects of surgical device
Description
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
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
time required to position the device during surgery
Description
time required to position the device during surgery (time is related with probability of side effect during surgery)
Time Frame
up to 36 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: animal model: lantrace female pigs of 20 kg of body weight Exclusion Criteria: any kind of illness in porcine subjects
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Chiaretti, MD, PhD, MSc
Organizational Affiliation
University of Roma La Sapienza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Animal House Agostino Gemelli University of Rome.
City
Rome
State/Province
RM
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
23635074
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.
Results Reference
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PubMed Identifier
20148633
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.
Results Reference
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PubMed Identifier
19572819
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.
Results Reference
background
PubMed Identifier
19063954
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.
Results Reference
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"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

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