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

NCT01959867 | Withdrawn

• 1 other identifier: TEI-BR-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

mastectomy; breast reconstruction; bovine; ADM; breast cancer; breast implants; breast expanders; radiation therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (5)

• No. Capsule Procedures

  12 months Post-Exchange

• Cosmetic Assessment

  12 months Post-Exchange

• Time to Completion

  12 months Post-Exchange

• Total number of OR procedures

  12 month follow-up visit

• Total number of visits

  12 month follow up visit

Study Arms (2)

SurgiMend® PRS (ADM)

EXPERIMENTAL

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

Device: SurgiMend® PRS

No Intervention

OTHER

Subjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion).

Other: No Intervention

Interventions

SurgiMend® PRS DEVICE

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

Also known as: ADM, acellular dermal matrix

SurgiMend® PRS (ADM)

No Intervention OTHER

Subjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion).

No Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2013
• First Posted: October 10, 2013
• Study Start: January 1, 2017
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 10, 2017

Record last verified: 2017-01