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

NCT04436887 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-06-22

No results posted yet for this study

Summary

The aim of the present study is to analyse feasibility, safety and Incisional Hernia rate using a prophylactic sub lay non-absorbable mesh \[Parietex Progrip (Medtronic) \] in order to prevent Incisional Hernia following midline emergent laparotomy in clean and clean-contaminated wounds.

Conditions

  • Incisional Hernia
  • Wound 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.

Sponsors & Collaborators

  • Francesco Pizza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2020-06-01
Completion
2020-06-01

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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 NCT04436887 on ClinicalTrials.gov