"BP as a New Device for Surgery and Solid Cancer and Hematopoietic System Tumors Treatment. Effects of BP Implantation"

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 in humans, in laparotomic procedures and as a new device for the treatment of solid cancer and hematopoietic system tumors.

The experimentation on this new material, preliminary conducted on breed female rabbit New Zeeland, will be applicable to human, if the results in terms of toxicity and durability will be comfortable.

Conditions

• Hernia of Abdominal Wall
• Incisional Hernia

Interventions

PROCEDURE

BP selfstanding felt

intervention of laparotomy with the incision of 10 cm navel-pubis will be performed, splaying of the skin and subcutaneous layers, then will be incised the fascia plane, and muscles. Ten rabbits (hereafter defined as BPR1-BPR10) will receive 2x2cm2 samples of BP selfstanding felt in a pocket created between muscular fascia and large muscles of the abdominal wall.

PROCEDURE

PP mesh

intervention of laparotomy with the incision of 10 cm navel-pubis will be performed, splaying of the skin and subcutaneous layers, then will be incised the fascia plane, and muscles. A 2x2cm2 sample of PR (polypropylene) prosthesis was implanted without stitches into a pocket between large abdominal muscle and abdominal fascia

PROCEDURE

BP intraperitoneal mesh

Laparotomy on the linea alba carried out deeply for entering into the abdominal cavity, a 2x2cm2 BP sample implantation with the rough side facing the parietal peritoneum surface and the smooth and brilliant surface facing to the visceral peritoneum and gut

PROCEDURE

control group

observational intervention in 5 rabbits with the same body weight and the same age will be observed and will be feeded in the same way of the BP device intraperitoneal implanted group

Sponsors & Collaborators

• University of Sannio

  collaborator OTHER

• Appialab Veterinary Reseach Labaratory

  collaborator UNKNOWN

• Catholic University of the Sacred Heart

  collaborator OTHER

• Istituto Superiore di Sanità

  collaborator OTHER

• 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

3 Months

Max Age

6 Months

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2015-08-31

Completion

2015-08-31

Countries

• Italy

Study Locations