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"BP as a New Device for Surgery and Solid Cancer and Hematopoietic System Tumors Treatment. Effects of BP Implantation" (DM159)

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ClinicalTrials.gov Identifier: NCT02328352
Recruitment Status : Unknown
Verified December 2014 by Massimo Chiaretti, University of Roma La Sapienza.
Recruitment status was:  Active, not recruiting
First Posted : December 31, 2014
Last Update Posted : December 31, 2014
Sponsor:
Collaborators:
University of Sannio
Appialab Veterinary Reseach Labaratory
Catholic University of the Sacred Heart
Istituto Superiore di Sanità
Information provided by (Responsible Party):
Massimo Chiaretti, University of Roma La Sapienza

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 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.


Condition or disease Intervention/treatment Phase
Hernia of Abdominal Wall Incisional Hernia Procedure: BP selfstanding felt Procedure: PP mesh Procedure: BP intraperitoneal mesh Procedure: control group Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Buckypaper as a New Device in the Treatment of Some Solid Cancer and Hematopoietic System Tumors and as a New Fixing Device for Prosthetic Surgery. In Vivo Study on Effects of BP Implantation, Preliminary to Human Surgical Applications
Study Start Date : October 2010
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: BP selfstanding felt

laparotomy intervention 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.

V-Loc 180 (ref VLOCL0024, lot. A1D0899)

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.
Other Names:
  • BP (Buckypaper NanoLab Inc., Newton, MA 02458 USA)
  • V-Loc 180 (ref VLOCL0024, lot. A1D0899)

Active Comparator: 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 PP mesh was implanted without stitches into a pocket between large abdominal muscle and abdominal fascia.

Other names: V-Loc 180 (ref VLOCL0024, lot. A1D0899) PR Parietene mesh Tyco (ref. PP3030, lot. SIK00587)

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
Other Names:
  • Other names: V-Loc 180 (ref VLOCL0024, lot. A1D0899)
  • PR Parietene mesh Tyco (ref. PP3030, lot. SIK00587)

Experimental: BP intraperitoneal mesh
A surgical scar was performed on the abdominal linea alba and carried out deeply for entering into the abdominal cavity. In five rabbits (BPR21-BPR25). A 2x2cm2 BP intraperitoneal mesh was then be inserted with the rough side facing the parietal peritoneum surface and the smooth and brilliant surface facing to the visceral peritoneum and gut.
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
Other Names:
  • BP (Buckypaper NanoLab Inc., Newton, MA 02458 USA)
  • V-Loc 180 (ref VLOCL0024, lot. A1D0899)

Active Comparator: control group
Five rabbits (R26-R30) will be used as control group.
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
Other Name: famale 3000 gr New Zeeland rabbits (Harland)




Primary Outcome Measures :
  1. number of moths without surgical hernia recurrence [ Time Frame: 54 weeks ]
    Durability (in months) without recurrence of hernia and incisional hernia of surgical device.


Secondary Outcome Measures :
  1. number of mm displacement from the point of implantation (at 12 weeks after BP implantation) [ Time Frame: 3 months ]
    Ability (number of mm displacement from the point of implantation at 12 weeks after BP implantation) of the BP as bio-adhesive tape for prosthetic materials to avoid displacement of implanted prosthesis.

  2. number of BP fragments in bioptic samples of Bowman capsule [ Time Frame: 12 weeks ]
    toxicology of BP measured as number of BP fragments in bioptic samples of Bowman capsule of the nephron at 12 weeks

  3. number of viable tumor cells in cultures after 48 hours of exposition to BP [ Time Frame: 48 hours ]
    antineoplastic activity of BP device in the treatment of some solid cancer and hematopoietic system tumors: this item is measured ex vivo as the ability of BP to inhibit tumor cell replication (number of viable tumor cells in cultures after 48 hours of exposition to BP)


Other Outcome Measures:
  1. delta of value of creatinine, transaminasis and PT, PTT, fibinogen from the T0 to 12 weeks. [ Time Frame: 12 weeks ]
    toxicology of BP measured as modifications of values (delta) of creatinine, transaminasis and PT, PTT, fibinogen in blood samples from the T0 to 12 weeks.



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Ages Eligible for Study:   3 Months to 6 Months   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: animal model: New Zeeland female rabbits of 3000 gr of body weight -

Exclusion Criteria: any kind of illness in rabbit subjects

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328352


Locations
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Italy
National Health Institute (ISS Istituto Superiore di Sanità), Viale Regina Elena 299
Rome, Roma, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
University of Sannio
Appialab Veterinary Reseach Labaratory
Catholic University of the Sacred Heart
Istituto Superiore di Sanità
Investigators
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Principal Investigator: Massimo Chiaretti, MD, PhD, MSc University of Roma La Sapienza
Additional Information:
Publications of Results:

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Responsible Party: Massimo Chiaretti, Dr, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02328352    
Other Study ID Numbers: DM SALUTE 159/2010 20/09/2010
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014
Keywords provided by Massimo Chiaretti, University of Roma La Sapienza:
Buckypaper (BP) of Multi-Walled Carbon Nanotubes (MWCNTs)
surgical hernia prosthesis
abdominal wall defects surgery
prosthesis adhesion
disaster preparation and recovery hernia
Abdominal Wall Disaster Surgery
Fixation of prosthetic materials in general surgery
Additional relevant MeSH terms:
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Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes