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

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ClinicalTrials.gov Identifier: NCT02277262
Recruitment Status : Unknown
Verified October 2014 by Federico Coccolini, A.O. Ospedale Papa Giovanni XXIII.
Recruitment status was:  Recruiting
First Posted : October 28, 2014
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):
Federico Coccolini, A.O. Ospedale Papa Giovanni XXIII

Study Description
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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%.

Condition or disease Intervention/treatment Phase
Incisional Hernia Device: Biological swine dermis not cross-linked prosthesis positioning in incisional hernia prevention Procedure: Direct suture of the anterior abdominal wall fascia Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : October 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment arm
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
 Device: Biological swine dermis not cross-linked prosthesis positioning in incisional hernia prevention
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.
Other Name: Biological swine dermis not-cross-linked prosthesis positioning
Active Comparator: Control arm
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
 Procedure: Direct suture of the anterior abdominal wall fascia
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.


Outcome Measures
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Primary Outcome Measures :
  1. Incisional hernia rate [ Time Frame: 3 months ]
  2. Incisional hernia rate [ Time Frame: 6 months ]
  3. Incisional hernia rate [ Time Frame: 12 months ]
  4. Incisional hernia rate [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Morbidity [ Time Frame: 0 months ]
  2. Morbidity [ Time Frame: 3 months ]
  3. Morbidity [ Time Frame: 6 months ]
  4. Morbidity [ Time Frame: 12 months ]
  5. Morbidity [ Time Frame: 24 months ]
  6. Length of surgery [ Time Frame: Day 0 ]
  7. Time to drain removal [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks ]
  8. Length of stay in hospital [ Time Frame: At the discharge, an expected average of 1-2 weeks after the intervention ]
  9. Mortality [ Time Frame: 0 months ]
  10. Mortality [ Time Frame: 3 months ]
  11. Mortality [ Time Frame: 6 months ]
  12. Mortality [ Time Frame: 12 months ]
  13. Mortality [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277262


Locations
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Italy
Papa Giovanni XXIII hospital Recruiting
Bergamo, Italy, 24128
Contact: Federico Coccolini, MD    0039-0352673412    federico.coccolini@gmail.com   
Contact: Luca Ansaloni, MD    0039-0352673483    lansaloni@hpg23.it   
Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
More Information
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Responsible Party: Federico Coccolini, General Surgeon, A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier: NCT02277262    
Other Study ID Numbers: 154-14
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Keywords provided by Federico Coccolini, A.O. Ospedale Papa Giovanni XXIII:
peritonitis patients
Additional relevant MeSH terms:
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Peritonitis
Incisional Hernia
Hernia
Pathological Conditions, Anatomical
Intraabdominal Infections
 Infection
Peritoneal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes