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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02277262
Other study ID # 154-14
Secondary ID
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


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
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