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The DIEP-Flap as a Model of Ischemia-Reperfusion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00482469
First Posted: June 5, 2007
Last Update Posted: January 7, 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
It is our goal to study the mechanism of ischemia-reperfusion injury. Our DIEP-operation is actually a clinical model of ischemia-reperfusion. Ischemia-reperfusion injury has never been directly studied in a human, clinical model of autologous transplant.

Condition
Ischemia-Reperfusion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The DIEP-Flap as a Model of Ischemia-Reperfusion

Further study details as provided by Maastricht University Medical Center:

Biospecimen Retention:   Samples With DNA
Frozen tissue.

Enrollment: 45
Study Start Date: April 2007
Study Completion Date: November 2008
  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
Sampling Method:   Probability Sample
Study Population
Clinical patients hospitalized for surgery.
Criteria

Inclusion Criteria:

  • patient is undergoing a DIEP-breast reconstruction, unilateral as well as bilateral
  • is aged 18 years or older

Exclusion Criteria:

  • diabetes mellitus
  • diseases of the kidneys
  • diseases of the liver
  • patients who are taking 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): NCT00482469


Locations
Netherlands
Department of Plastic and Reconstructive surgery, Maastricht University Hospital
Maastricht, Netherlands, P.O. Box 5800-6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Study Chair: René R Van der Hulst, MD, PhD Maastricht University Hospital
Principal Investigator: Marieke GW Van den Heuvel, MD Maastricht University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. R. van der Hulst, M.D., University Hospital Maastricht
ClinicalTrials.gov Identifier: NCT00482469     History of Changes
Other Study ID Numbers: MEC 07-2-004
First Submitted: June 4, 2007
First Posted: June 5, 2007
Last Update Posted: January 7, 2009
Last Verified: January 2009

Keywords provided by Maastricht University Medical Center:
ischemia-reperfusion
ischemia
reperfusion
DIEP-flap
flap

Additional relevant MeSH terms:
Ischemia
Pathologic Processes