SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01959867
• Other study ID #: TEI-BR-001
• Status: Withdrawn
• Phase: N/A
• First received: September 27, 2013
• Last updated: January 6, 2017
• Start date: January 2017
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• SurgiMend® PRS
Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion).

Other:
• No 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Capsular Contracture Rate	Capsular Contracture Rate (Baker III/IV): Reduction from control through 12 months after expander-to-permanent implant exchange	12 months Post-Exchange	No
Primary	Breast Q	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.	12 months Post-Exchange	No
Secondary	No. Capsule Procedures	Number of capsule procedures performed	12 months Post-Exchange	Yes
Secondary	Cosmetic Assessment	Patient: (BREAST-Q Reconstruction Module) Surgeon: (panel review of standard photographs)	12 months Post-Exchange	No
Secondary	Time to Completion	Time to Completion (expand-to-implant exchange)	12 months Post-Exchange	No
Secondary	Total number of OR procedures	Procedural Attributes: Total number of OR procedures	12 month follow-up visit	No
Secondary	Total number of visits	Procedural Attributes: Total number of ("in office" and OR procedures)	12 month follow up visit	No