PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM)

Incisional Hernia Clinical Trial

— PROPHYBIOM  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02277262
• Other study ID #: 154-14
• Status: Recruiting
• Phase: Phase 4
• First received: October 14, 2014
• Last updated: October 25, 2014
• Start date: October 2014
• Est. completion date: October 2018

Study information

• Verified date: October 2014
• Source: A.O. Ospedale Papa Giovanni XXIII
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 2018
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Incisional Hernia

Intervention

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.

Locations

Country	Name	City	State
Italy	Papa Giovanni XXIII hospital	Bergamo

Sponsors (1)

Lead Sponsor	Collaborator
A.O. Ospedale Papa Giovanni XXIII

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incisional hernia rate		3 months	Yes
Primary	Incisional hernia rate		6 months	Yes
Primary	Incisional hernia rate		12 months	Yes
Primary	Incisional hernia rate		24 months	Yes
Secondary	Morbidity		0 months	Yes
Secondary	Morbidity		3 months	Yes
Secondary	Morbidity		6 months	Yes
Secondary	Morbidity		12 months	Yes
Secondary	Morbidity		24 months	Yes
Secondary	Length of surgery		Day 0	No
Secondary	Time to drain removal		participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks	No
Secondary	Length of stay in hospital		At the discharge, an expected average of 1-2 weeks after the intervention	No
Secondary	Mortality		0 months	Yes
Secondary	Mortality		3 months	Yes
Secondary	Mortality		6 months	Yes
Secondary	Mortality		12 months	Yes
Secondary	Mortality		24 months	Yes