The DIEP-Flap as a Model of Ischemia-Reperfusion
January 6, 2009 updated by: Maastricht University Medical Center
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
45
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
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Maastricht, Netherlands, P.O. Box 5800-6202 AZ
- Department of Plastic and Reconstructive surgery, Maastricht University Hospital
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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
Female
Sampling Method
Probability Sample
Study Population
Clinical patients hospitalized for surgery.
Description
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
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 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.
General Publications
- van den Heuvel MG, Bast A, Haenen GR, Ambergen AW, Mermans JF, van der Hulst RR. The role of antioxidants in ischaemia-reperfusion in a human DIEP flap model. J Plast Reconstr Aesthet Surg. 2012 Dec;65(12):1706-11. doi: 10.1016/j.bjps.2012.06.010. Epub 2012 Jul 11.
- van den Heuvel MG, Mermans JF, Ambergen AW, van der Hulst RR. Perfusion of the deep inferior epigastric perforator flap measured by laser Doppler imager. Ann Plast Surg. 2011 Jun;66(6):648-53. doi: 10.1097/SAP.0b013e3181e37bc8.
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
April 1, 2007
Study Completion (ACTUAL)
November 1, 2008
Study Registration Dates
First Submitted
June 4, 2007
First Submitted That Met QC Criteria
June 4, 2007
First Posted (ESTIMATE)
June 5, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
January 7, 2009
Last Update Submitted That Met QC Criteria
January 6, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC 07-2-004
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.