NCT00482469

Brief Summary

It is our goal to study the mechanism of ischemia-reperfusion injury. Our DIEP-operation is actually a clinical model of ischemia-reperfusion. Ischemia-reperfusion injury has never been directly studied in a human, clinical model of autologous transplant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2007

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

January 7, 2009

Status Verified

January 1, 2009

First QC Date

June 4, 2007

Last Update Submit

January 6, 2009

Conditions

Ischemia-Reperfusion

Keywords

ischemia-reperfusionischemiareperfusionDIEP-flapflap

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Clinical patients hospitalized for surgery.

You may qualify if:

  • patient is undergoing a DIEP-breast reconstruction, unilateral as well as bilateral
  • is aged 18 years or older

You may not qualify if:

  • diabetes mellitus
  • diseases of the kidneys
  • diseases of the liver
  • patients who are taking immunosuppressants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Plastic and Reconstructive surgery, Maastricht University Hospital

Maastricht, P.O. Box 5800-6202 AZ, Netherlands

Location

Related Publications (2)

  • van den Heuvel MG, Bast A, Haenen GR, Ambergen AW, Mermans JF, van der Hulst RR. The role of antioxidants in ischaemia-reperfusion in a human DIEP flap model. J Plast Reconstr Aesthet Surg. 2012 Dec;65(12):1706-11. doi: 10.1016/j.bjps.2012.06.010. Epub 2012 Jul 11.

    PMID: 22789619DERIVED

  • van den Heuvel MG, Mermans JF, Ambergen AW, van der Hulst RR. Perfusion of the deep inferior epigastric perforator flap measured by laser Doppler imager. Ann Plast Surg. 2011 Jun;66(6):648-53. doi: 10.1097/SAP.0b013e3181e37bc8.

    PMID: 21233705DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Frozen tissue.

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • René R Van der Hulst, MD, PhD

    Maastricht University Hospital

    STUDY CHAIR

  • Marieke GW Van den Heuvel, MD

    Maastricht University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2007

First Posted

June 5, 2007

Study Start

April 1, 2007

Study Completion

November 1, 2008

Last Updated

January 7, 2009

Record last verified: 2009-01

Locations

NL(1)