PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM)

A.O. Ospedale Papa Giovanni XXIII

Status and phase: Unknown; Phase 4

Conditions: Incisional Hernia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02277262

154-14

Details and patient eligibility

About

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%.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Treatment arm

Experimental group

Description:

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

Treatment:

Device: Biological swine dermis not cross-linked prosthesis positioning in incisional hernia prevention

Control arm

Active Comparator group

Description:

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:

Procedure: Direct suture of the anterior abdominal wall fascia