PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM)

NCT02277262 | Unknown Phase 4

• 1 other identifier: 154-14
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

peritonitis patients

Outcome Measures

Primary Outcomes (4)

• Incisional hernia rate

  3 months

• Incisional hernia rate

  6 months

• Incisional hernia rate

  12 months

• Incisional hernia rate

  24 months

Secondary Outcomes (13)

• Morbidity

  0 months

• Morbidity

  3 months

• Morbidity

  6 months

• Morbidity

  12 months

• Morbidity

  24 months

Study Arms (2)

Treatment arm

EXPERIMENTAL

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

Control arm

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Biological swine dermis not-cross-linked prosthesis positioning

Treatment arm

Direct suture of the anterior abdominal wall fascia 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.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• A.O. Ospedale Papa Giovanni XXIII: lead

Study Sites (1)

Papa Giovanni XXIII hospital

Bergamo, 24128, Italy

RECRUITING

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgeon

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 28, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2018
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

IT (1)