Breast Cancer
Conditions
Keywords
mastectomy, breast reconstruction, bovine, ADM, breast cancer, breast implants, breast expanders, radiation therapy
Brief summary
This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.
Interventions
DEVICESurgiMend® PRS
Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion).
OTHERNo Intervention
Subjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion).
Sponsors
Integra LifeSciences Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is at least 18 years of age * Patient is female * Patient is undergoing immediate, two-stage breast reconstruction following mastectomy with or without the use of SurgiMend® PRS * Patient has previously undergone pre-mastectomy XRT for breast cancer, with lumpectomy or partial mastectomy, with the previously irradiated breast now being reconstructed (with or without contralateral mastectomy & reconstruction) * Patient utilized a textured expander only * Patient utilized a smooth gel permanent implant only * Patient has agreed and is able to comply with the study follow-up requirements * Patient or guardian has provided consent for participation
Exclusion criteria
* Patient is undergoing single-stage breast reconstruction * Patient is undergoing a delayed reconstruction * Patient is undergoing reconstruction using a smooth tissue expander, textured gel breast implant or any saline breast implant. * Patient is undergoing planned reconstruction using autologous tissue * Patient has a known hypersensitivity to collagen or bovine derived materials * Patient is currently pregnant, nursing, or planning a pregnancy during the course of the study * Patient who has had pre-mastectomy XRT bilaterally for breast cancer (either at the same time or separated in time)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Capsular Contracture Rate | 12 months Post-Exchange | Capsular Contracture Rate (Baker III/IV): Reduction from control through 12 months after expander-to-permanent implant exchange |
| Breast Q | 12 months Post-Exchange | No decrease in overall patient satisfaction from control as measured by the BREAST-Q Reconstruction Module Patient Satisfaction with Breasts survey, all questions a-p. Increase in patient satisfaction from control as measured by the BREAST-Q Reconstruction Module Patient Satisfaction with Breasts survey, questions related to capsular contracture. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Completion | 12 months Post-Exchange | Time to Completion (expand-to-implant exchange) |
| No. Capsule Procedures | 12 months Post-Exchange | Number of capsule procedures performed |
| Total number of visits | 12 month follow up visit | Procedural Attributes: Total number of (in office and OR procedures) |
| Total number of OR procedures | 12 month follow-up visit | Procedural Attributes: Total number of OR procedures |
| Cosmetic Assessment | 12 months Post-Exchange | Patient: (BREAST-Q Reconstruction Module) Surgeon: (panel review of standard photographs) |
Outcome results
None listed