Status:
UNKNOWN
PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM)
Lead Sponsor:
A.O. Ospedale Papa Giovanni XXIII
Conditions:
Incisional Hernia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 settin...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2018
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT02277262
Start Date
October 1 2014
End Date
October 1 2018
Last Update
October 28 2014
Active Locations (1)
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1
Papa Giovanni XXIII hospital
Bergamo, Italy, 24128