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NCT01997619 Clinical Trial

Biological Mesh Repair of Complex Hernias in High Risk Patients

Hernia Clinical Trial

Official title:
Biological Mesh Repair of Complex Ventral Hernias in High Risk Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01997619
Other study ID # 30245705
Secondary ID
Status Completed
Phase N/A
First received November 24, 2013
Last updated November 24, 2013
Start date November 2011
Est. completion date November 2013

Study information
Verified date November 2013
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial Summary

Complex ventral hernia repair is a significant surgical challenge with high frequencies of both wound complications and recurrence. The Ventral Hernia Working Group (VHWG) described in 2010 recommendations regarding grading and technique of repair, which we have followed since November 2011.The purpose of the this study was to evaluate our results after biologic mesh repair of complex hernias.

Description:

Obervational study

Primare outcome: Surgical site occurence

Secondary outcome: Hernia recurrence

Biolocal mesh: Ventral hernia repair in a population with severe co-morbidity and contaminated hernia.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date November 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: Abdominal wall reconstruction with biological mesh -

Exclusion Criteria: Pregancy,

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary surgical site occurence Wound infections, redness, seromas, dehiesience at the hernia implant site 30 days Yes
Secondary hernia recurrence Hernia recurrence at the hernia implant site 20 months Yes
See also
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Active, not recruiting NCT02439060 - PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit) N/A
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