PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM)

NCT ID: NCT02277262

Last Updated: 2014-10-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2018-10-31

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%.

Conditions

Incisional Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

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

Group Type: ACTIVE_COMPARATOR

Direct suture of the anterior abdominal wall fascia

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Biological swine dermis not-cross-linked prosthesis positioning

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

A.O. Ospedale Papa Giovanni XXIII

OTHER

Sponsor Role: lead

Responsible Party

Federico Coccolini

General Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Papa Giovanni XXIII hospital

Bergamo, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Federico Coccolini, MD

Role: primary

federico.coccolini@gmail.com

0039-0352673412

Luca Ansaloni, MD

Role: backup

lansaloni@hpg23.it

0039-0352673483

Other Identifiers

154-14

Identifier Type: -

Identifier Source: org_study_id