Breast Reconstruction Clinical Trial
Official title:
Free Flap Breast Reconstruction Using Virtual Surgical Planning and 3-D Modeling
Verified date | February 2024 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if 3D modeling and Virtual Planning Surgery can improve the clinical outcome with patient who have a mastectomy requiring breast reconstruction.
Status | Terminated |
Enrollment | 38 |
Est. completion date | August 1, 2022 |
Est. primary completion date | August 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - Subjects must have histologically or cytologically confirmed breast caner undergoing delayed or immediate breast reconstruction. - Performance statusECOG Performance status = 2 - Subjects must have normal organ and marrow function as defined below: - Hemoglobin = 10.0 g/dl - Leukocytes = 3,000/mcL - Absolute neutrophil count = 1,500/mcL - Platelet count = 100,000/mcL - Total bilirubin within normal institutional limits - AST (SGOT) = 2.5 X institutional upper limit of normal - ALT (SGPT) = 2.5 X institutional upper limit of normal - Serum Creatinine within normal institutional limits - Subjects must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Subjects receiving any prior abdominoplasty or abdominal liposuction, or patient that plan on undergoing radiation therapy after reconstruction. - History of allergic reactions attributed to compounds of similar chemical or biologic composition to IV contrast. - Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant or breastfeeding women are excluded from this study because IV contrast and CT scans have the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with breast cancer, breastfeeding should be discontinued. - Unsuitable donor site volume or vasculature based on pre-operative imaging or physical exam. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic, Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean operative time | Mean operative time using 3D medical models of the abdomen to create a virtual plan to assist reconstruction. | Up to 6 months after reconstruction | |
Primary | Mean dissection time | Mean dissection time using 3D medical models of the abdomen to create a virtual plan to assist reconstruction. | Up to 6 months after reconstruction | |
Secondary | Aesthetic outcomes as measured by the Harris scale | Aesthetic outcomes as measured by the Harris scale, which ranges from 1-4, with higher scores indicating worse outcomes. | Up to 1 year after reconstruction | |
Secondary | Donor site complications | Number of donor site complications will be reported | Up to 1 year after reconstruction | |
Secondary | Incidence of fat necrosis as measured by a grading system | Incidence of fat necrosis will be measured in the postoperative period using a classification system. Grade I necrosis will be defined as minimal requiring no surgical intervention; Grade II necrosis will be minor with some aesthetic defect requiring primary excision and closure; Grade III necrosis will be defined as requiring secondary procedures after excision to achieve satisfactory cosmesis; Grade IV necrosis will involve a necrosectomy requiring a either a completely new flap or at least a second flap to address such problems; Grade V necrosis will be defined as complete flap failure 5.
Higher grade of fat necrosis is worse. |
1 week, 2 weeks, 6 weeks, 3 months, and 6 months post reconstruction. | |
Secondary | Patient satisfaction as measured by BREAST-Q scores | Patient satisfaction as measured by BREAST-Q scores which ranges from 4-16, with higher scores indicating more satisfaction with breasts. | Up to 1 year after reconstruction |
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