The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Maastricht University Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by:
Maastricht University Medical Center Identifier:
First received: January 12, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
The investigators will examine whether administration of certain medications will decrease or prevent ischemia-reperfusion injury.

Condition Intervention Phase
Drug: Antioxidant
Other: Placebo
Drug: Anti-inflammatory drug
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study

Resource links provided by NLM:

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Antioxidant concentrations [ Time Frame: 0,5-24 hours ]

Estimated Enrollment: 30
Study Start Date: February 2009
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo tablet and iv
Other: Placebo
Placebo tablet and iv
Experimental: 2
Placebo tablet and intervention iv
Drug: Antioxidant
Antioxidant iv bolus
Experimental: 3
Intervention tablet and placebo iv
Drug: Anti-inflammatory drug
Anti-inflammatory tablet


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients undergoing breast reconstruction

Exclusion Criteria:

  • Diabetes mellitus
  • Kidney or liver disease
  • Use of immunosuppressants
  Contacts and Locations
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Please refer to this study by its identifier: NCT00821158

Maastricht University Medical Center
Maastricht, Netherlands, P.O. Box 5800, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Study Chair: R. van der Hulst, M.D., Phd Maastricht Universtity Medical Center
Principal Investigator: Marieke van den Heuvel, M.D. Maastricht University Medical Center
  More Information

Responsible Party: R. van der Hulst, M.D., Phd, Maastricht University Medical Center Identifier: NCT00821158     History of Changes
Other Study ID Numbers: MEC 25-11-2008 
Study First Received: January 12, 2009
Last Updated: January 12, 2009

Additional relevant MeSH terms:
Pathologic Processes
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs processed this record on January 19, 2017