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

Phase 3

• Conditions: Ischemia-Reperfusion
• Interventions: Other: Placebo; Drug: Antioxidant; Drug: Anti-inflammatory drug

• Registration Number: NCT00821158
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-01
• Study First Submitted: 2009-01-12
• Study First Submitted QC: 2009-01-12
• Last Update Submitted: 2009-01-12
• Study First Posted: 2009-01-13
• Last Update Posted: 2009-01-13
• Study Start: 2009-02
• Primary Completion: 2011-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Patients undergoing breast reconstruction

Exclusion Criteria

• Diabetes mellitus
• Kidney or liver disease
• Use of immunosuppressants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Placebo tablet and iv
2	Antioxidant	Placebo tablet and intervention iv
3	Anti-inflammatory drug	Intervention tablet and placebo iv

Primary Outcome Measures

Name	Time	Method
Antioxidant concentrations	0,5-24 hours

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands