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

June 22, 2018 updated by: University Hospital, Ghent
Mesh repair for open incisional hernia repair with fibrin sealant or with drainage

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent
      • Leuven, Belgium
        • UZ Gasthuisberg Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Study group (Tisseel®)
Drug: Tisseel®
Mesh repair for open incisional hernia repair with fibrin sealant
OTHER: 2
Control group
Procedure: Drainage
Mesh repair for open incisional hernia repair with drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospital stay
Time Frame: At time of discharge
At time of discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative drainage volume
Time Frame: Day 0,1, 2, 3 ? and at day of removal
Day 0,1, 2, 3 ? and at day of removal
Perioperative morbidity rate
Time Frame: At time of discharge
At time of discharge
Pain measured using VAS
Time Frame: Daily till discharge and after 3 weeks post-surgery
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
Preoperatively, at time of discharge, 2 weeks after discharge, 6 weeks after discharge and 1 year post surgery
Recurrence
Time Frame: At one year
At one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Baxter Healthcare Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 27, 2010

Primary Completion (ACTUAL)

October 14, 2014

Study Completion (ACTUAL)

May 24, 2018

Study Registration Dates

First Submitted

October 16, 2008

First Submitted That Met QC Criteria

October 16, 2008

First Posted (ESTIMATE)

October 17, 2008

Study Record Updates

Last Update Posted (ACTUAL)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 22, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/433

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Incisional Hernia

Clinical Trials on Tisseel®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe