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

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00775034
First received: October 16, 2008
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  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
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:

MedlinePlus related topics: Hernia
U.S. FDA Resources

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 2013
Estimated Primary Completion Date: June 2013 (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

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

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00775034     History of Changes
Other Study ID Numbers: 2008/433
Study First Received: October 16, 2008
Last Updated: January 31, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal
Fibrin Tissue Adhesive
 Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013