SPY Intra-Operative Angiography & Skin Perfusion in Immediate Breast Reconstruction w/ Implants - Full Text View

Purpose

We hope to learn the value of the SPY ELITE® intra-operative angiography in reducing post-operative complications associated with low breast skin blood flow after breast reconstruction using implants.

Condition	Intervention
Breast Cancer	Procedure: SPY Intra-Operative Angiography


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	The Role of SPY Intra-Operative Angiography in Determining Adequate Skin Perfusion in Immediate Breast Reconstruction With Implants

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Reconstruction Plastic and Cosmetic Surgery

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: During surgery ] [ Designated as safety issue: No ]
To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: Immediately post operative ] [ Designated as safety issue: No ]
To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Establish the percentage of patients with ischemia or necrosis in the first year post surgery. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Number and type of complications in the first year. [ Time Frame: 12 months ] [ Designated as safety issue: No ]


Estimated Enrollment:	100
Study Start Date:	June 2011
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	October 2015 (Final data collection date for primary outcome measure)

Intervention Details:

Calculated per patient

Other Name: Novadaq SPY

Detailed Description:

Breast cancer is the most common malignancy among women, and over 180,000 women will be diagnosed with this disease in 2008. Last year, over 57,000 breast reconstructive procedures were performed, of which prosthetic reconstruction constituted 76%. Immediate reconstruction has been favored over delayed procedures for psychological and technical reasons. However, immediate breast reconstruction is associated with significantly higher complication rates (50-52%) than delayed procedures (32-36%), especially when a prosthetic technique is used. For prosthetic reconstructions, the most significant early complications include necrosis of the mastectomy skin flaps, infection, delayed wound healing and exposure of the implant. The published incidence of these complications ranges between 10% and 40% and is predominantly associated with malperfusion of mastectomy skin flaps. Thus, evaluation of skin perfusion and elimination of poorly vascularized areas could help reduce the high rate of complications in immediate breast reconstruction.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The patient population includes women with unilateral or bilateral breast cancer undergoing immediate or delayed breast reconstruction.

Criteria

Inclusion Criteria:

3.1.0 Ability to understand and the willingness to sign a written informed consent document.

3.1.1 Signed written informed consent.

3.1.2 Women with local or regional recurrences after previous breast conserving surgery.

3.1.3 Women undergoing delayed post mastectomy reconstruction.

3.1.4 Women undergoing prophylactic mastectomy.

3.1.5 Women with invasive or non-invasive breast cancer, receiving breast conserving surgery with or without reduction mammoplasty or mastectomy, with or without immediate reconstruction.

3.1.6 Women of 18 years of age or older.

3.1.7 ECOG or Karnofsky Performance Status 0,1,2.

3.1.8 Basic Metabolic Panel within 6 months

3.1.9 Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

Exclusion Criteria:

3.2.1 History of liver or kidney failure will not be eligible.

3.2.2 Allergies to iodine containing products will not be eligible.

3.2.3 Women who are pregnant will not be eligible.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315119

Locations


United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators


Principal Investigator:	Geoffrey C. Gurtner	Stanford University

More Information

No publications provided


Responsible Party:	Stanford University
ClinicalTrials.gov Identifier:	NCT01315119 History of Changes
Other Study ID Numbers:	BRS0005, BRS0005
Study First Received:	March 11, 2011
Last Updated:	December 18, 2014
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on March 03, 2015