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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00482469
Other study ID # MEC 07-2-004
Secondary ID
Status Completed
Phase N/A
First received June 4, 2007
Last updated January 6, 2009
Start date April 2007
Est. completion date November 2008

Study information

Verified date January 2009
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date November 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Department of Plastic and Reconstructive surgery, Maastricht University Hospital Maastricht

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

See also
  Status Clinical Trial Phase
Terminated NCT02254642 - Effects of Ischemic Preconditioning After Aortic Clamping N/A
Not yet recruiting NCT00821158 - The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study Phase 3