Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair - Full Text View

Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair (DREAM)

This study is not yet open for participant recruitment.

Verified by University Hospital, Ghent, October 2008

Sponsors and Collaborators:	University Hospital, Ghent Baxter Healthcare Corporation
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00775034

Purpose

Mesh repair for open incisional hernia repair with fibrin sealant or with drainage

Condition	Intervention	Phase
Incisional Hernia	Drug: Tisseel® Procedure: Drainage	Phase IV

MedlinePlus related topics: Hernia

Drug Information available for: Fibrin Beriplast

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

Hospital stay [ Time Frame: At time of discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Postoperative drainage volume [ Time Frame: Day 0,1, 2, 3 ? and at day of removal ] [ Designated as safety issue: No ]
Perioperative morbidity rate [ Time Frame: At time of discharge ] [ Designated as safety issue: Yes ]
Pain measured using VAS [ Time Frame: Daily till discharge and after 3 weeks post-surgery ] [ Designated as safety issue: Yes ]
Quality of life by SF-36 questionnaire [ Time Frame: Preoperatively, at time of discharge, 2 weeks after discharge, 6 weeks after discharge and 1 year post surgery ] [ Designated as safety issue: No ]
Recurrence [ Time Frame: At one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Study group (Tisseel®)	Drug: Tisseel® Mesh repair for open incisional hernia repair with fibrin sealant
2 Control group	Procedure: Drainage Mesh repair for open incisional hernia repair with drainage

Eligibility

Criteria

Inclusion Criteria:

All patients with a large incisional hernia >5cm diameter that needs elective repair with mesh augmentation

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775034

Contacts

Contact: Frederik Berrevoet, MD

Locations

Sponsors and Collaborators

University Hospital, Ghent

Baxter Healthcare Corporation

Investigators

Principal Investigator:

Frederik Berrevoet, MD

University Hospital, Ghent

More Information

Website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

Responsible Party:	University Hospital Ghent ( Frederik Berrevoet )
Study ID Numbers:	2008/433
Study First Received:	October 16, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00775034
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products; Belgium: Institutional Review Board

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Fibrin Tissue Adhesive
Hernia

ClinicalTrials.gov processed this record on January 16, 2009