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

January 12, 2009 updated by: Maastricht University Medical Center
The investigators will examine whether administration of certain medications will decrease or prevent ischemia-reperfusion injury.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

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

  • Netherlands
      • Maastricht, Netherlands, P.O. Box 5800, 6202 AZ
        • Maastricht University Medical Center

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

Description

Inclusion Criteria:

  • Patients undergoing breast reconstruction

Exclusion Criteria:

  • Diabetes mellitus
  • Kidney or liver disease
  • Use of 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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Antioxidant concentrations
Time Frame: 0,5-24 hours
0,5-24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • 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

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

February 1, 2009

Primary Completion (Anticipated)

February 1, 2011

Study Registration Dates

First Submitted

January 12, 2009

First Submitted That Met QC Criteria

January 12, 2009

First Posted (Estimate)

January 13, 2009

Study Record Updates

Last Update Posted (Estimate)

January 13, 2009

Last Update Submitted That Met QC Criteria

January 12, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 25-11-2008

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.

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