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

Ischemia-Reperfusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00821158
• Other study ID #: MEC 25-11-2008
• Status: Not yet recruiting
• Phase: Phase 3
• First received: January 12, 2009
• Last updated: January 12, 2009
• Start date: February 2009

Study information

• Verified date: January 2009
• Source: Maastricht University Medical Center
• Contact: Marieke van den Heuvel, M.D.
• Phone: 0031-43-3875496
• Email: m.vandenheuvel[@]ah.unimaas.nl
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The investigators will examine whether administration of certain medications will decrease or prevent ischemia-reperfusion injury.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing breast reconstruction

Exclusion Criteria:

• Diabetes mellitus

• Kidney or liver disease

• Use of immunosuppressants

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ischemia
• Ischemia-Reperfusion

Intervention

Drug:
• Antioxidant
Antioxidant iv bolus

Other:
• Placebo
Placebo tablet and iv

Drug:
• Anti-inflammatory drug
Anti-inflammatory tablet

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antioxidant concentrations		0,5-24 hours	No