The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00821158 |
Recruitment Status : Unknown
Verified January 2009 by Maastricht University Medical Center.
Recruitment status was: Not yet recruiting
First Posted : January 13, 2009
Last Update Posted : January 13, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ischemia-Reperfusion | Drug: Antioxidant Other: Placebo Drug: Anti-inflammatory drug | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study |
Study Start Date : | February 2009 |
Estimated Primary Completion Date : | February 2011 |

Arm | Intervention/treatment |
---|---|
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 |
- Antioxidant concentrations [ Time Frame: 0,5-24 hours ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821158
Contact: Marieke van den Heuvel, M.D. | 0031-43-3875496 | m.vandenheuvel@ah.unimaas.nl | |
Contact: R. van der Hulst, M.D., Phd | 0031-43-3877481 | r.vander.hulst@mumc.nl |
Netherlands | |
Maastricht University Medical Center | |
Maastricht, Netherlands, P.O. Box 5800, 6202 AZ | |
Contact: Marieke van den Heuvel, M.D. 0031-43-3875496 m.vandenheuvel@ah.unimaas.nl | |
Principal Investigator: Marieke van den Heuvel, M.D. |
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 |
Responsible Party: | R. van der Hulst, M.D., Phd, Maastricht University Medical Center |
ClinicalTrials.gov Identifier: | NCT00821158 |
Other Study ID Numbers: |
MEC 25-11-2008 |
First Posted: | January 13, 2009 Key Record Dates |
Last Update Posted: | January 13, 2009 |
Last Verified: | January 2009 |
Ischemia Pathologic Processes Anti-Inflammatory Agents Antioxidants |
Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs |