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Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment

NCT02061527 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2018-04-24

No results posted yet for this study

Summary

To evaluate breast reconstruction with implants using biological mesh (Strattice™) in the setting of breast cancer treatment.

Conditions

Interventions

PROCEDURE

Reconstruction with ADM.

If the patient wishes to undergo immediate implant based reconstruction, and meets the selection criteria for entering the study, she is randomly selected to be treated according to Group A or Group B. Group A (no intervention) will be reconstructed with expander or anatomical gel implant without ADM, using complete muscle coverage. Group B (Intervention) will be reconstructed with expander or anatomical gel implant using partial muscle coverage in conjunction with ADM.

PROCEDURE

Skin or nipple sparing mastectomy

Mastectomy for invasive or pre-invasive breast cancer

PROCEDURE

Reconstruction with implant

Immediate breast reconstruction with implant

PROCEDURE

Total submuscular coverage

Implant based breast reconstruction with total submuscular coverage

PROCEDURE

Partial submuscular coverage

Implant based breast reconstruction with partial submuscular coverage

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • LifeCell

    collaborator INDUSTRY

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Fredrik Lohmander, MD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-04-30
Completion
2017-05-31

Countries

  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02061527 on ClinicalTrials.gov