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

Integra LifeSciences

Status: Withdrawn

Conditions: Breast Cancer

Treatments: Other: No Intervention; Device: SurgiMend® PRS

Study type: Interventional

Funder types: Industry

Identifiers

NCT01959867

TEI-BR-001

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

SurgiMend® PRS (ADM)

Experimental group

Description:

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

Treatment:

Device: SurgiMend® PRS

No Intervention

Other group

Description:

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

Treatment:

Other: No Intervention