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Safety and Efficacy of Prophylactic Re-sorbable Biosynthetic Mesh Following Midline Laparotomy in Clean/Contaminated Field.

NCT04471311 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2023-10-30

No results posted yet for this study

Summary

The aim of the present study is to analyse the feasibility, safety and IH rate using a prophylactic sublay biosynthetic BIO-A (GORE) mesh in order to prevent incisional hernia following midline laparotomy in clean-contaminated and contaminated wounds. The study was designed as a double-blind randomized controlled trial comparing the running suture alone to the running suture reinforced with biosynthetic mesh (BIOA) in sub lay position.

Conditions

  • Incisional Hernia After Midline Laparotomy

Interventions

PROCEDURE

Sub-lay mesh supported closure

A 4 cm space is created between posterior rectus sheath and rectus muscle, widening 2 cm at each side of midline. Both posterior rectus sheath edges are sutured using a running slowly absorbable suture. Above the arcuate line, posterior layer is reinforced suturing the peritoneum and the posterior rectus sheath; below the arcuate line, the posterior layer is reinforced suturing the peritoneum and the trasversalis fascia. Anterior layer is re-established suturing the anterior rectus sheath. A 3 cm BIO-A Mesh strip is sutureless placed between the posterior rectus sheath and the rectus muscle with an overlap of 1,5 cm at each side. In laparotomies \>20 cm two stripes of 15 cm each is designed. The midline anterior rectus sheath is closed using a running slowly absorbable suture , covering the mesh.

DEVICE

BIO-A (GORE) mesh

3 cm BIO-A Mesh strip

Sponsors & Collaborators

  • Azienda Sanitaria Locale Napoli 2 Nord

    lead OTHER

Principal Investigators

  • Francesco Pizza · Azienda Sanitaria Locale Napoli 2 Nord

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04471311 on ClinicalTrials.gov