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

Maastricht University Medical Centre (MUMC)

Status and phase: Unknown; Phase 3

Conditions: Ischemia-Reperfusion

Treatments: Drug: Antioxidant; Other: Placebo; Drug: Anti-inflammatory drug

Study type: Interventional

Funder types: Other

Identifiers

NCT00821158

MEC 25-11-2008

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing breast reconstruction

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo tablet and iv

Treatment:

Other: Placebo

2

Experimental group

Description:

Placebo tablet and intervention iv

Treatment:

Drug: Antioxidant

3

Experimental group

Description:

Intervention tablet and placebo iv

Treatment:

Drug: Anti-inflammatory drug