PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM)

Phase 4

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

• Registration Number: NCT02277262
• Lead Sponsor: A.O. Ospedale Papa Giovanni XXIII

Brief Summary

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%.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-10
• Study Start: 2014-10
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-25
• Last Update Submitted: 2014-10-25
• Study First Posted: 2014-10-28
• Last Update Posted: 2014-10-28
• Primary Completion: 2016-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	Direct suture of the anterior abdominal wall fascia	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
Treatment arm	Biological swine dermis not cross-linked prosthesis positioning in incisional hernia prevention	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

Primary Outcome Measures

Name	Time	Method
Incisional hernia rate	24 months

Secondary Outcome Measures

Name	Time	Method
Mortality	24 months
Length of surgery	Day 0
Morbidity	24 months
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

Trial Locations

Locations (1)

Papa Giovanni XXIII hospital; 🇮🇹 Bergamo, Italy