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

NCT01554267 | Unknown

• 1 other identifier: 127891
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

In the investigators previous study of 51 breast reconstructions (32 patients), we compared three different assessments of vascular perfusion of tissue; clinical judgment, fluorescein dye angiography (FDA) and laser-assisted indocyanine green dye angiography (ICG). Because tissue with poor perfusion becomes necrotic and can compromise the success of breast reconstruction, it is important that tissue with poor perfusion be removed at the time of the reconstructive surgery. However, it is also important to remove the least amount of potentially necrotic tissue as possible so that the breast reconstruction is not compromised by lack of skin. Therefore finding the best way to assess potentially necrotic tissue is a vital clinical question. In the initial study the 3 different assessment methods which were made at the time of surgery were compared to the subsequent development of necrotic tissue. In the initial study, clinical judgment was the basis for determining the tissue removed because it had the potential to become necrotic. The investigators collected data with the FDA system and ICG system, but this data was not used in making the clinical decisions. The study followed the progression of tissue to overt necrosis and this clinical outcome was then compared to the predictions made by the three different assessment strategies. The investigators found that clinical judgment failed to detect tissue which subsequently became necrotic in 21 out of 51 instances for a failure rate of 41%. The FDA system predicted larger areas of potentially necrotic tissue than clinical judgment, but was found to over-predict the area that became necrotic by 82% - 88% (88% if all cases were included and 82% if only those cases which subsequently developed necrosis were included). Although the ICG system is similar to the FDA system in that a dye is used to assess perfusion, the ICG system has enhanced software which improves the estimated perfusion. The ICG system provided 90% sensitivity and 100% specificity in the predicted vs. actual necrotic tissue at specific absolute perfusion units values. Hypothesis: Using the values of absolute perfusion units discovered in the previous study and implementing its use in the operating room will decrease all-inclusive necrosis rates to below 10%, reflecting a 31% decrease in the investigators necrosis rate.

Conditions

Breast Cancer; Breast Reconstruction; Mastectomy

Keywords

Mastectomy skin flap necrosis; Breast reconstruction; Indocyanine Green Dye

Outcome Measures

Primary Outcomes (1)

• Mastectomy Skin Flap Necrosis

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

  30 days postop

Secondary Outcomes (4)

• Infection

  30 days postop

• Wound Dehiscence or Implant Extrusion

  30 days postop

• Seroma/Hematoma

  30 days postop

• Removal or Loss of Implant

  30 days postop

Study Arms (1)

Mastectomy Skin Flap SPY Excision

EXPERIMENTAL

Single arm study where areas of necrosis predicted by Laser-Assisted Indocyanine Green Dye Angiography (SPY system) will be excised intraoperatively during breast reconstruction surgery.

Device: Laser-Assisted ICG Dye Angiography (SPY System)

Interventions

Laser-Assisted ICG Dye Angiography (SPY System) DEVICE

7.5-10mg of ICG dye will be injected at 2 different time points during breast reconstruction with the assistance of the SPY system to determine areas of skin with poor blood flow. These areas are excised during the operation in order to decrease postoperative complications including mastectomy skin flap necrosis and reconstruction failure.

Also known as: Lifecell SPY System, Novadaq SPY System

Mastectomy Skin Flap SPY Excision

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being scheduled for unilateral or bilateral mastectomy (prophylactic or for the treatment of cancer) followed by breast construction using a Tissue Expander
• Consent to participation in the study.

You may not qualify if:

• Refusal to consent to participation in the study
• Inability to tolerate the administration of indocyanine green dye due to iodine allergy
• A positive pregnancy test during preoperative evaluation.

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Duc T Bui, MD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

• Brett T Phillips, MD

  Stony Brook University

  STUDY DIRECTOR

Central Study Contacts

Brett T Phillips, MD

CONTACT

631-444-8020; brett.phillips@stonybrook.edu

Sami U Khan, MD

CONTACT

631-444-9394; sami.khan@stonybrook.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: March 14, 2012
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

US (1)