Overview

This trial is active, not recruiting.

Conditions hernia, incisional hernia
Treatments ppl fixation by bp, ppl mesh
Phase phase 1/phase 2
Sponsor University of Roma La Sapienza
Collaborator A Martinelli
Start date March 2013
End date October 2015
Trial size 30 participants
Trial identifier NCT02137018, 36Pa

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
control group: laparotomy with PPL mesh implantation (traditional method)
ppl mesh PPL Premilene mesh B Braun (ref. 1064435, lot. 112313)
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.
(Experimental)
laparotomic surgery with PPL mesh fixation by BP (new fixing method)
ppl fixation by bp PPL Premilene mesh B Braun (ref. 1064435, lot. 112313)
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.
(Active Comparator)
control group: laparoscopy with PPL mesh implantation (traditional method)
ppl mesh PPL Premilene mesh B Braun (ref. 1064435, lot. 112313)
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.
(Experimental)
laparoscopic surgery with PPL mesh fixation by BP (new fixing method)
ppl fixation by bp PPL Premilene mesh B Braun (ref. 1064435, lot. 112313)
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.

Primary Outcomes

Measure
Time of durability without side effects of surgical device
time frame: up to 36 months

Secondary Outcomes

Measure
time required to position the device during surgery
time frame: up to 36 months

Eligibility Criteria

Female participants from 3 months up to 6 months old.

Inclusion Criteria: - animal model: lantrace female pigs of 20 kg of body weight Exclusion Criteria: - any kind of illness in porcine subjects

Additional Information

Official title "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".
Principal investigator Massimo Chiaretti, MD, PhD, MSc
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of Roma La Sapienza.