NCT02263261

Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction

Reconstructive, Aesthetic and Patient Reported Outcomes Associated With the Use of Flex HD Pliable, Perforated Human Acellular Dermal Matrix in Implant-Based Breast Reconstruction: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Musculoskeletal Transplant Foundation · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a prospective, single-site pilot study in which outcomes associated with the use of Flex HD® Pliable™ Perforated, Human Acellular Dermal Matrix and an implant which are used in post-mastectomy breast reconstruction will be obtained. The data collected will include reconstructive outcomes, aesthetic outcomes and patient-reported outcomes in order to ascertain advantages and disadvantages of using this particular HADM in post-mastectomy breast reconstruction.

Conditions

• Mastectomy
• Breast Reconstruction

Interventions

Type	Name	Description
OTHER	Flex HD Pliable Perforated HADM	Human Acellular Dermal Matrix

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-06-01
• Completion: 2016-11-01
• First posted: 2014-10-13
• Last updated: 2018-09-20

Locations

2 sites across 1 country: United States