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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Hernia, Incisional Hernia

Intervention / Treatment
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* Device: PPL fixation by BP
* Device: PPL mesh


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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laparotomy with PPL mesh implantation<br>control group: laparotomy with PPL mesh implantation (traditional method) | Device: PPL mesh<br>* 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.<br>* Other names: V-Loc 180 (ref. VLOCL0024, lot. A1D0998);|
| Experimental: laparotomy with PPL fixation by BP<br>laparotomic surgery with PPL mesh fixation by BP (new fixing method) | Device: PPL fixation by BP<br>* 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.<br>* Other names: The BP (NanoLab Inc, Newton, MA 02458 USA);|
| Active Comparator: laparoscopy with PPL mesh implantation<br>control group: laparoscopy with PPL mesh implantation (traditional method) | Device: PPL mesh<br>* 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.<br>* Other names: V-Loc 180 (ref. VLOCL0024, lot. A1D0998);|
| Experimental: laparoscopy with PPL fixation by BP<br>laparoscopic surgery with PPL mesh fixation by BP (new fixing method) | Device: PPL fixation by BP<br>* 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.<br>* Other names: The BP (NanoLab Inc, Newton, MA 02458 USA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of durability without side effects of surgical device | We are testing the time (months/year) of durability without side effects of a new fixing method for prosthetic materials for abdominal wall hernias and wall defects repairing on pig model | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time required to position the device during surgery | time required to position the device during surgery (time is related with probability of side effect during surgery) | up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hernia, incisional hernia, device, pig