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The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study

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 January 2009 by Maastricht University Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00821158
First Posted: January 13, 2009
Last Update Posted: January 13, 2009
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.
Information provided by:
Maastricht University Medical Center
  Purpose
The investigators will examine whether administration of certain medications will decrease or prevent ischemia-reperfusion injury.

Condition Intervention Phase
Ischemia-Reperfusion Drug: Antioxidant Other: Placebo Drug: Anti-inflammatory drug Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Antioxidant concentrations [ Time Frame: 0,5-24 hours ]

Estimated Enrollment: 30
Study Start Date: February 2009
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo tablet and iv
Other: Placebo
Placebo tablet and iv
Experimental: 2
Placebo tablet and intervention iv
Drug: Antioxidant
Antioxidant iv bolus
Experimental: 3
Intervention tablet and placebo iv
Drug: Anti-inflammatory drug
Anti-inflammatory tablet

  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:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing breast reconstruction

Exclusion Criteria:

  • Diabetes mellitus
  • Kidney or liver disease
  • Use of immunosuppressants
  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): NCT00821158


Contacts
Contact: Marieke van den Heuvel, M.D. 0031-43-3875496 m.vandenheuvel@ah.unimaas.nl
Contact: R. van der Hulst, M.D., Phd 0031-43-3877481 r.vander.hulst@mumc.nl

Locations
Netherlands
Maastricht University Medical Center Not yet recruiting
Maastricht, Netherlands, P.O. Box 5800, 6202 AZ
Contact: Marieke van den Heuvel, M.D.    0031-43-3875496    m.vandenheuvel@ah.unimaas.nl   
Principal Investigator: Marieke van den Heuvel, M.D.         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Study Chair: R. van der Hulst, M.D., Phd Maastricht Universtity Medical Center
Principal Investigator: Marieke van den Heuvel, M.D. Maastricht University Medical Center
  More Information

Responsible Party: R. van der Hulst, M.D., Phd, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00821158     History of Changes
Other Study ID Numbers: MEC 25-11-2008
First Submitted: January 12, 2009
First Posted: January 13, 2009
Last Update Posted: January 13, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Ischemia
Pathologic Processes
Anti-Inflammatory Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs