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Impact of ADM in Reduction of Surgical Complexity of Breast Reconstructions With Implants (Nava)

NCT01853436 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-05-25

No results posted yet for this study

Summary

The objective of this study is to demonstrate that acellular dermal matrix, Strattice™ Reconstructive Tissue Matrix, can reduce the surgical complexity and post-operative pain of breast reconstructions with implants by avoiding one more surgical step in the operating room.

Conditions

  • Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction

Interventions

DEVICE

Strattice™ Reconstructive Tissue Matrix

Experimental arm: Device: Strattice Reconstructive Tissue Matrix Unilateral or bilateral mastectomy. Immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant with ADM, single stage reconstruction technique. Control arm: Device: no device. Immediate breast tissue expander/implant based reconstruction with a two-stage reconstruction technique.

Sponsors & Collaborators

  • LifeCell

    lead INDUSTRY

Principal Investigators

  • Andrea Spano, MD · Fondazione IRCCS Instituto Nazionale dei Tumori

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2017-04-30
Completion
2017-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01853436 on ClinicalTrials.gov