NCT02277262

PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: A.O. Ospedale Papa Giovanni XXIII · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-10-01
• Completion: 2018-10-01
• First posted: 2014-10-28
• Last updated: 2014-10-28

Locations

1 site across 1 country: Italy