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

NARecruitingINTERVENTIONAL
Enrollment

151

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

June 30, 2024

Study Completion Date

June 30, 2024

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

Trial Locations (1)

Unknown

RECRUITING

francesco Pizza, Naples

All Listed Sponsors
lead

Azienda Sanitaria Locale Napoli 2 Nord

OTHER