Status:
COMPLETED
Prophylactic Sub-lay Non-absorbable Mesh Following Midline Laparotomy: PROMETHEUS (PROphylactic Mesh Trial Evaluation UltraSound)
Lead Sponsor:
Francesco Pizza
Conditions:
Incisional Hernia
Wound Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Incisio...
Detailed Description
The study is a double-blinded randomized trial, comparing the widely recommended midline laparotomy closure using a running slowly absorbable suture to closure with the aid of a permanent sub-lay mesh...
Eligibility Criteria
Inclusion
- age \> 18 years
- Clean-contaminated wounds
- midline laparotomy \>10 cm
- Informed consent
Exclusion
- age \< 18 years;
- life expectancy \< 24 months (as estimated by the operating surgeon), -
- pregnancy
- immunosuppressant therapy within 2 weeks before surgery
- clean, contaminated and dirty wounds
- wound length\<10 cm.
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04436887
Start Date
January 1 2016
End Date
June 1 2020
Last Update
June 22 2020
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