The DIEP-Flap as a Model of Ischemia-Reperfusion

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00482469
First received: June 4, 2007
Last updated: January 6, 2009
Last verified: January 2009
  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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Maastricht University Medical Center

Additional 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
Study First Received: June 4, 2007
Last Updated: January 6, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014