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

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

Interventions

DEVICE

BP self-standing felt 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.

DEVICE

PR Parietene mesh 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.

Sponsors & Collaborators

• University of Sannio

  collaborator OTHER

• P Consentino Appialab Veterinary Reseach Labaratory

  collaborator UNKNOWN

• Catholic University of the Sacred Heart

  collaborator OTHER

• E D'Amore Istituto Superiore Sanità

  collaborator UNKNOWN

• University of Roma La Sapienza

  lead OTHER

Principal Investigators

• Massimo Chiaretti, MD, PhD, MSc · University of Roma La Sapienza

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

2 Months

Max Age

4 Months

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-01-31

Primary Completion

2015-08-31

Completion

2015-12-31

Countries

• Italy

Study Locations