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 currently recruiting participants.

Verified by University Hospital, Ghent, April 2009

First Received: October 16, 2008 Last Updated: April 14, 2009 History of Changes

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: Beriplast

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

no written informed consent
'hostile' abdomen
emergency surgery (incarcerated hernia)
parastomal hernia
incisional hernia outside the midline
recurrent incisional hernia

Contacts and Locations

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

Contacts

Contact: Frederik Berrevoet, MD

Frederik.berrevoet@ugent.be

Locations

Belgium
University Hospital Ghent	Recruiting
Ghent, Belgium, 9000
Principal Investigator: Frederik Berrevoet, MD

Sponsors and Collaborators

University Hospital, Ghent

Baxter Healthcare Corporation

Investigators

Principal Investigator:

Frederik Berrevoet, MD

University Hospital, Ghent

More Information

Additional Information:

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

No publications provided

Responsible Party:	University Hospital Ghent ( Frederik Berrevoet )
Study ID Numbers:	2008/433
Study First Received:	October 16, 2008
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00775034 History of Changes
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

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Hernia

ClinicalTrials.gov processed this record on May 07, 2009