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The Use of Laser-Assisted Indocyanine Green Dye Angiography to Predict Intraoperative Mastectomy Skin Flap Viability During Breast Reconstruction


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Breast Reconstruction, Mastectomy

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Trial Information

The Use of Laser-Assisted Indocyanine Green Dye Angiography to Predict Intraoperative Mastectomy Skin Flap Viability During Breast Reconstruction


The investigators current rate of the development of all-inclusive mastectomy skin necrosis
was approximately 41%. This means that current methods of clinical assessment fail to
identify regions of mastectomy skin with poor blood flow that lead to necrosis in 41% of
patients. The investigators know that using the SPY imaging system is more sensitive for
necrosis than clinical assessment. With SPY Q analysis the investigators hope to obtain 90%
sensitivity, 100% specificity at absolute perfusion unit values identified in the previous
study. The investigators do not anticipate obtaining a 0% all-inclusive necrosis rate but
do believe they can eliminate all clinically significant necrosis that would result in
operative debridement or removal of implant. The less severe forms of necrosis including
epidermolysis and incisional necrosis are self-limiting and usually do not require invasive
interventions.


Inclusion Criteria:



1. Being scheduled for unilateral or bilateral mastectomy (prophylactic or for the
treatment of cancer) followed by breast construction using a Tissue Expander

2. Consent to participation in the study.

Exclusion Criteria:

1. Refusal to consent to participation in the study

2. Inability to tolerate the administration of indocyanine green dye due to iodine
allergy

3. A positive pregnancy test during preoperative evaluation.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Mastectomy Skin Flap Necrosis

Outcome Description:

All-inclusive mastectomy skin flap necrosis including: epidermolysis, partial/superficial necrosis, and full-thickness necrosis.

Outcome Time Frame:

30 days postop

Safety Issue:

No

Principal Investigator

Duc T Bui, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stony Brook University

Authority:

United States: Institutional Review Board

Study ID:

127891

NCT ID:

NCT01554267

Start Date:

March 2012

Completion Date:

August 2013

Related Keywords:

  • Breast Cancer
  • Breast Reconstruction
  • Mastectomy
  • Mastectomy skin flap necrosis
  • Breast reconstruction
  • Indocyanine Green Dye
  • Breast Neoplasms

Name

Location

Stony Brook UniversityStony Brook, New York  11794