"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)

June 12, 2015 updated by: Massimo Chiaretti, University of Roma La Sapienza

"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".

"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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00168
        • Animal House Agostino Gemelli University of Rome.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • any kind of illness in porcine subjects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: laparotomy with PPL mesh implantation
control group: laparotomy with PPL mesh implantation (traditional method)
Device: PPL mesh
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.
Other Names:
  • PPL Premilene mesh B Braun (ref. 1064435, lot. 112313)
  • PPL Parietene mesh Tyco (ref. PP3030, lot. SIK00587)
  • V-Loc 180 (ref. VLOCL0024, lot. A1D0998)
Experimental: laparotomy with PPL fixation by BP
laparotomic surgery with PPL mesh fixation by BP (new fixing method)
Device: PPL fixation by BP
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.
Other Names:
  • 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)
Active Comparator: laparoscopy with PPL mesh implantation
control group: laparoscopy with PPL mesh implantation (traditional method)
Device: PPL mesh
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.
Other Names:
  • PPL Premilene mesh B Braun (ref. 1064435, lot. 112313)
  • PPL Parietene mesh Tyco (ref. PP3030, lot. SIK00587)
  • V-Loc 180 (ref. VLOCL0024, lot. A1D0998)
Experimental: laparoscopy with PPL fixation by BP
laparoscopic surgery with PPL mesh fixation by BP (new fixing method)
Device: PPL fixation by BP
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.
Other Names:
  • 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of durability without side effects of surgical device
Time Frame: up to 36 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
time required to position the device during surgery
Time Frame: up to 36 months
time required to position the device during surgery (time is related with probability of side effect during surgery)
up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Investigators

  • Principal Investigator: Massimo Chiaretti, MD, PhD, MSc, University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 6, 2014

First Submitted That Met QC Criteria

May 9, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Estimate)

June 15, 2015

Last Update Submitted That Met QC Criteria

June 12, 2015

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36Pa

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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