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Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies

NCT03293862 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2019-04-17

No results posted yet for this study

Summary

Facial dehiscence elicit high morbidity and mortality. This complication may arise in more than 8.5% of high-risk patients. Addressing risk factors and optimizing surgical technique are guarded as mainstay measures for prevention, but their efficacy is questionable. The aim of this study is to analyze the influence of using a polypropylene onlay prophylactic mesh on the incidence of fascial dehiscence in emergency surgery and associated complications.

Conditions

  • Surgical Wound Dehiscence

Interventions

DEVICE

prophylactic polypropilene mesh

Placement of onlay polypropilene prophylactic mesh after midline fascial closure.

PROCEDURE

Midline Fascial Closure

midline fascial closure using uninterrupted PDS 0 suture

DEVICE

vacuum drainage system

Placement of a subcutaneous vacuum drainage system

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-03-31
Completion
2018-02-28

Countries

  • Brazil

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 NCT03293862 on ClinicalTrials.gov