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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
Baxter Healthcare Corporation
Information provided by (Responsible Party):
University Hospital, Ghent Identifier:
First received: October 16, 2008
Last updated: December 4, 2014
Last verified: December 2014
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ 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: 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
Control group
Procedure: Drainage
Mesh repair for open incisional hernia repair with drainage


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00775034

University Hospital Ghent
Ghent, Belgium, 9000
UZ gasthuisberg Leuven
Leuven, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Baxter Healthcare Corporation
Principal Investigator: Frederik Berrevoet, MD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent Identifier: NCT00775034     History of Changes
Other Study ID Numbers: 2008/433 
Study First Received: October 16, 2008
Last Updated: December 4, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board

Additional relevant MeSH terms:
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Fibrin Tissue Adhesive
Coagulants processed this record on January 17, 2017