PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM)

Phase 4

• Conditions: Incisional Hernia

• 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

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