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

Primary Purpose

Incisional Hernia

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Biological swine dermis not cross-linked prosthesis positioning in incisional hernia prevention
Direct suture of the anterior abdominal wall fascia
Sponsored by
A.O. Ospedale Papa Giovanni XXIII
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Incisional Hernia focused on measuring peritonitis patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Papa Giovanni XXIII hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment arm

Control arm

Arm 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

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

Outcomes

Primary Outcome Measures

Incisional hernia rate
Incisional hernia rate
Incisional hernia rate
Incisional hernia rate

Secondary Outcome Measures

Morbidity
Morbidity
Morbidity
Morbidity
Morbidity
Length of surgery
Time to drain removal
Length of stay in hospital
Mortality
Mortality
Mortality
Mortality
Mortality

Full Information

First Posted
October 14, 2014
Last Updated
October 25, 2014
Sponsor
A.O. Ospedale Papa Giovanni XXIII
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1. Study Identification

Unique Protocol Identification Number
NCT02277262
Brief Title
PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM)
Acronym
PROPHYBIOM
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
A.O. Ospedale Papa Giovanni XXIII

4. Oversight

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia
Keywords
peritonitis patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm
Arm Type
Experimental
Arm 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
Arm Title
Control arm
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
Biological swine dermis not cross-linked prosthesis positioning in incisional hernia prevention
Other Intervention Name(s)
Biological swine dermis not-cross-linked prosthesis positioning
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Direct suture of the anterior abdominal wall fascia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incisional hernia rate
Time Frame
3 months
Title
Incisional hernia rate
Time Frame
6 months
Title
Incisional hernia rate
Time Frame
12 months
Title
Incisional hernia rate
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Morbidity
Time Frame
0 months
Title
Morbidity
Time Frame
3 months
Title
Morbidity
Time Frame
6 months
Title
Morbidity
Time Frame
12 months
Title
Morbidity
Time Frame
24 months
Title
Length of surgery
Time Frame
Day 0
Title
Time to drain removal
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks
Title
Length of stay in hospital
Time Frame
At the discharge, an expected average of 1-2 weeks after the intervention
Title
Mortality
Time Frame
0 months
Title
Mortality
Time Frame
3 months
Title
Mortality
Time Frame
6 months
Title
Mortality
Time Frame
12 months
Title
Mortality
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Papa Giovanni XXIII hospital
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Federico Coccolini, MD
Phone
0039-0352673412
Email
federico.coccolini@gmail.com
First Name & Middle Initial & Last Name & Degree
Luca Ansaloni, MD
Phone
0039-0352673483
Email
lansaloni@hpg23.it

12. IPD Sharing Statement

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PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM)

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