UnknownNot Applicable

The Effects of Indocyanine Green Angiography (IGA) on Deep Inferior Epigastric Artery Perforator (DIEP) Flap Design and Post-Operative Fat Necrosis

United States100 participantsStarted 2014-01

Plain-language summary

The aim of this study is to prospectively evaluate the effect of intra-operative Indocyanine green angiography (IGA) on both flap design and rate of post-operative fat necrosis in patients undergoing autologous breast reconstruction utilizing the Deep Inferior Epigastric Artery Perforator (DIEP) flap.

Who can participate

Age range25 Years – 65 Years

SexFEMALE

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Inclusion criteria

✓. Female patients at the University of Washington
✓. Aged twenty-five to sixty-five years
✓. Pursuing immediate or delayed, DIEP-based, autologous, microsurgical breast reconstruction at the University of Washington Medical Center

Exclusion criteria

✕. Patients unsuitable for autologous, microsurgical breast reconstruction utilizing the DIEP flap - i.e. patients who have undergone prior extensive abdominal surgeries, have inadequate abdominal tissue bulk, who cannot comply with standardized post-operative restrictions / assessments or patients afflicted with a medical condition(s) precluding prolonged general anesthesia and surgery.
✕. Patients who have a known allergy to contrast media will also be excluded from this study.
✕. Patients unable to read and write in English will be excluded.

What they're measuring

Rate of post-operative fat necrosis

Timeframe: 3-6 months post-operatively

Trial details

NCT IDNCT02144961

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-01

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