The DIEP-Flap as a Model of Ischemia-Reperfusion

Ischemia-Reperfusion Clinical Trial

Official title:

The DIEP-Flap as a Model of Ischemia-Reperfusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482469
• Other study ID #: MEC 07-2-004
• 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
• 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

• Ischemia
• Ischemia-Reperfusion

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,