PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM)

Study Overview
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Brief Summary
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To evaluate the efficacy of the use of swine dermal collagen prosthesis implanted preperitoneally as a prophylactic procedure against incisional hernia in patients operated in urgency/emergency setting in contaminated/infected fields with peritonitis. The aim of the study is to reduce the incidence of incisional hernia from 50% to 20%.

Conditions
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Incisional Hernia

Intervention / Treatment
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* Device: Biological swine dermis not cross-linked prosthesis positioning in incisional hernia prevention
* Procedure: Direct suture of the anterior abdominal wall fascia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patients aged > 18 years old Clinical and/or laboratory and/or radiological evidence/signs of peritonitis of any origin (peritoneal reactivity, positive Blumberg sign, fever, free air/fluid in abdominal cavity, leucocytosis, increased CRP (C-reactive protein, lactic dehydrogenase (LDH), tachycardia, tachypnea, clinical or radiological evidence/suspect of bowel ischemia) Eventual strong suspect of possible bacterial translocation (reduction of the natural intestinal barrier against bacterial translocation, i.e. bowel ischemia, bowel overdistension, intestinal occlusion, etc.) Surgical indication for midline laparotomy independently from eventual previous laparotomies Informed consent Exclusion Criteria: • Patients aged < 18 years old Informed consent refusal No Clinical and/or laboratory and/or radiological evidence/signs of peritonitis of any origin. Surgical indication for laparotomies other than midline one Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>Patients randomized to this arm will be operated for the primary disease and at the end of the intervention the laparotomy will be closed reinforcing the suture with a swine dermis biological prosthesis positioned sublay | Device: Biological swine dermis not cross-linked prosthesis positioning in incisional hernia prevention<br>* The mesh placement will be preceded by the plane preparation. The subcutaneous tissue will be dissociated from the anterior rectum-muscles fascia. The retro-muscular rectum muscles plane will be dissected preparing a 5-6 cm pouch necessary to the prosthesis positioning. The mesh will be fixed with at least 8 long-lasting absorbable transfix stitched. The prosthesis will be placed with at least a 5 cm overlap. If the peritoneal plane can be sutured a Jackson-Pratt 10 suction drain will be placed under the prosthesis. A Jackson-Pratt 10 suction drain will always be placed over the prosthesis. Anterior rectum fascia will be closed by emi-continuous monofilament suture with an intermediate-reabsorbable-time suture. Another Jackson-Pratt 10 suction drain will be placed over the anterior fascia if the subcutaneous tissue is thick. No subcutaneous suture will be performed. Skin stapler or interrupted stitches will be used to close the skin plane.<br>* Other names: Biological swine dermis not-cross-linked prosthesis positioning;|
| Active Comparator: Control arm<br>Patients randomized to this arm will be operated for the primary disease and at the end of the intervention the laparotomy will be closed by emi-continuous monofilament sutures with an intermediate-reabsorbable-time suture | Procedure: Direct suture of the anterior abdominal wall fascia<br>* Anterior rectum fascia will be closed by emi-continuous monofilament suture with an intermediate-reabsorbable-time suture. No subcutaneous suture will be performed. Skin stapler or interrupted stitches will be used to close the skin plane.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional hernia rate |  | 3 months | 
| Incisional hernia rate |  | 6 months | 
| Incisional hernia rate |  | 12 months | 
| Incisional hernia rate |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity |  | 0 months | 
| Morbidity |  | 3 months | 
| Morbidity |  | 6 months | 
| Morbidity |  | 12 months | 
| Morbidity |  | 24 months | 
| Length of surgery |  | Day 0 | 
| Time to drain removal |  | participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks | 
| Length of stay in hospital |  | At the discharge, an expected average of 1-2 weeks after the intervention | 
| Mortality |  | 0 months | 
| Mortality |  | 3 months | 
| Mortality |  | 6 months | 
| Mortality |  | 12 months | 
| Mortality |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peritonitis patients