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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00775034
First Posted: October 17, 2008
Last Update Posted: December 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
University Hospital, Ghent
  Purpose
Mesh repair for open incisional hernia repair with fibrin sealant or with drainage

Condition Intervention Phase
Incisional Hernia Drug: Tisseel® Procedure: Drainage Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Hospital stay [ Time Frame: At time of discharge ]

Secondary Outcome Measures:
  • Postoperative drainage volume [ Time Frame: Day 0,1, 2, 3 ? and at day of removal ]
  • Perioperative morbidity rate [ Time Frame: At time of discharge ]
  • Pain measured using VAS [ Time Frame: Daily till discharge and after 3 weeks post-surgery ]
  • 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 ]
  • Recurrence [ Time Frame: At one year ]

Estimated Enrollment: 100
Study Start Date: November 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775034


Contacts
Contact: Frederik Berrevoet, MD Frederik.berrevoet@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Principal Investigator: Frederik Berrevoet, MD         
UZ gasthuisberg Leuven Recruiting
Leuven, Belgium
Principal Investigator: Prof. Dr. M. Miserez         
Sponsors and Collaborators
University Hospital, Ghent
Baxter Healthcare Corporation
Investigators
Principal Investigator: Frederik Berrevoet, MD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00775034     History of Changes
Other Study ID Numbers: 2008/433
First Submitted: October 16, 2008
First Posted: October 17, 2008
Last Update Posted: December 5, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics
Coagulants