Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction

Completed · Not applicable

Conditions studied: Mastectomy, Breast Reconstruction

In brief

Use of a HADM and implant in post-mastectomy breast reconstruction.

Key facts

Study ID

NCT02263261

Run by

Musculoskeletal Transplant Foundation

People needed

40

Starts

2015-03-01

Expected to finish

2016-11-01

Last updated by the study team

2018-09-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Scheduled to undergo a single or two-stage, tissue-assisted, implant breast reconstruction
• Mastectomy may be unilateral or bilateral, prophylactic or therapeutic
• Skin incision may be skin sparing, or nipple-areolar sparing
• Have signed written, informed consent
• Be at least 18 years of age

You may not qualify if…

• Patients undergoing autologous breast reconstruction
• Patients undergoing breast reconstruction following complications of breast augmentation, mastopexy, breast reduction, or breast conservation surgery (lumpectomy)
• Patients undergoing reconstruction after previously failed attempts at reconstruction
• Patients undergoing autologous breast reconstruction in conjunction with a tissue expander (such as a latissimus dorsi flap, DIEP flap)
• There will be no exclusions based on race or ethnicity
• BMI > 40
• Previous Radiation Treatment. Note: Post-operative radiation treatment does not exclude subjects from study continuation once enrolled.

Where it is running

• Liu Plastic surgery — Mountain View, California, United States
• Liu Plastic Surgery — San Jose, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.