PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM) (PROPHYBIOM)

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%.

Study Overview

• Status: Unknown
• Conditions: Incisional Hernia
• Intervention / Treatment: Device: Biological swine dermis not cross-linked prosthesis positioning in incisional hernia prevention; Procedure: Direct suture of the anterior abdominal wall fascia

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Bergamo, Italy, 24128
    • Recruiting
    • Papa Giovanni XXIII Hospital
    • Contact: Federico Coccolini, MD; Phone Number: 0039-0352673412; Email: federico.coccolini@gmail.com
    • Contact: Luca Ansaloni, MD; Phone Number: 0039-0352673483; Email: lansaloni@hpg23.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm; 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; 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.; Other Names: Biological swine dermis not-cross-linked prosthesis positioning
Active Comparator: Control arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Time Frame
Mortality	12 months
Mortality	24 months
Mortality	6 months
Mortality	3 months
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

Collaborators and Investigators

• Sponsor: A.O. Ospedale Papa Giovanni XXIII

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: October 14, 2014
• First Submitted That Met QC Criteria: October 25, 2014
• First Posted (Estimate): October 28, 2014

Study Record Updates

• Last Update Posted (Estimate): October 28, 2014
• Last Update Submitted That Met QC Criteria: October 25, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: peritonitis patients
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Peritoneal Diseases; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Intraabdominal Infections; Peritonitis; Incisional Hernia
• Other Study ID Numbers: 154-14