"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
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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