SPY Intra-Operative Angiography & Skin Perfusion in Immediate Breast Reconstruction w/ Implants
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Purpose
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.
| 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 |
- 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 ]
- 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: | June 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
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Procedure: SPY Intra-Operative Angiography
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
The patient population includes women with unilateral or bilateral breast cancer undergoing immediate or delayed breast reconstruction.
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| Contact: Shannon Meyer | (650) 724-1953 | smeyer27@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Shannon Meyer 650-724-1953 smeyer27@stanford.edu | |
| Contact: Cancer Clinical Trials Office (650) 498-7061 | |
| Principal Investigator: Geoffrey C. Gurtner | |
| Sub-Investigator: Irene L. Wapnir | |
| 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: | January 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013