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The DIEP-Flap as a Model of Ischemia-Reperfusion

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ClinicalTrials.gov Identifier: NCT00482469
Recruitment Status : Completed
First Posted : June 5, 2007
Last Update Posted : January 7, 2009
Sponsor:
Information provided by:
Maastricht University Medical Center

Brief Summary:
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 or disease
Ischemia-Reperfusion

Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The DIEP-Flap as a Model of Ischemia-Reperfusion
Study Start Date : April 2007
Actual Study Completion Date : November 2008



Biospecimen Retention:   Samples With DNA
Frozen tissue.


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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

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

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 Posted: June 5, 2007    Key Record Dates
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