"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 (36P)

University of Roma La Sapienza

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Incisional Hernia; Hernia

Treatments: Device: PPL mesh; Device: PPL fixation by BP

Study type: Interventional

Funder types: Other

Identifiers

NCT02137018

36Pa

Details and patient eligibility

About

"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.

Enrollment: 30 patients

Sex: Female

Ages: 3 to 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• animal model: lantrace female pigs of 20 kg of body weight

Exclusion criteria

• any kind of illness in porcine subjects

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 4 patient groups

laparotomy with PPL mesh implantation

Active Comparator group

Description:

control group: laparotomy with PPL mesh implantation (traditional method)

Treatment:

Device: PPL mesh

laparotomy with PPL fixation by BP

Experimental group

Description:

laparotomic surgery with PPL mesh fixation by BP (new fixing method)

Treatment:

Device: PPL fixation by BP

laparoscopy with PPL mesh implantation

Active Comparator group

Description:

control group: laparoscopy with PPL mesh implantation (traditional method)

Treatment:

Device: PPL mesh

laparoscopy with PPL fixation by BP

Experimental group

Description:

laparoscopic surgery with PPL mesh fixation by BP (new fixing method)

Treatment:

Device: PPL fixation by BP