"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

NCT02137018 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-06-15

No results posted yet for this study

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.

Conditions

  • Hernia
  • Incisional Hernia

Interventions

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.

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.

Sponsors & Collaborators

  • Martinelli, Andrea, M.D.

    collaborator INDIV
  • GA Carru

    collaborator UNKNOWN
  • AM Chiaretti

    collaborator UNKNOWN
  • F Faiola

    collaborator UNKNOWN
  • G Ceccarelli

    collaborator UNKNOWN
  • AI Chiaretti

    collaborator UNKNOWN
  • P Consentino

    collaborator UNKNOWN
  • E Valente

    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
3 Months
Max Age
6 Months
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-10-31
Completion
2015-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02137018 on ClinicalTrials.gov