Prophylactic Sub-lay Non-absorbable Mesh Following Midline Laparotomy: PROMETHEUS (PROphylactic Mesh Trial Evaluation UltraSound)

NACompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

January 1, 2016

Primary Completion Date

June 1, 2020

Study Completion Date

June 1, 2020

Conditions
Incisional HerniaWound Infection
Interventions
PROCEDURE

positioning of polypropylene strips for prophylactic purposes in closing the middle laparotomies to prevent the incisional hernia

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 arcuate line, posterior layer was performed suturing peritoneum and posterior rectus sheath; below arcuate line, posterior layer was performed suturing peritoneum and trasversalis fascia. Anterior layer was performed suturing anterior rectus sheath. A suture length to wound length ratio of 4:1 is recommended. A 4-cm Parietex Progrip Mesh strip was placed between the posterior rectus sheath and rectus muscle with an overlap of at least 2 cm at each side, suture less. In laparotomies \>20 cm two stripes of 15 cm each were designed. The midline anterior rectus sheath was closed using a running slowly absorbable suture, covering the mesh. A suture length to wound length ratio of 4:1 is recommended.

All Listed Sponsors
lead

Francesco Pizza

OTHER

NCT04436887 - Prophylactic Sub-lay Non-absorbable Mesh Following Midline Laparotomy: PROMETHEUS (PROphylactic Mesh Trial Evaluation UltraSound) | Biotech Hunter | Biotech Hunter