Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction

Not Applicable

Completed

• Conditions: Breast Reconstruction; Mastectomy
• Interventions: Other: Flex HD Pliable Perforated HADM

• Registration Number: NCT02263261
• Lead Sponsor: Musculoskeletal Transplant Foundation

Brief 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.

Study Timeline

• Study First Submitted: 2014-10-06
• Study First Submitted QC: 2014-10-10
• Study First Posted: 2014-10-13
• Status Verified: 2015-03
• Study Start: 2015-03
• Primary Completion: 2016-06
• Study Completion: 2016-11
• Last Update Submitted: 2018-09-18
• Last Update Posted: 2018-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Flex HD Pliable Perforated HADM	Flex HD Pliable Perforated HADM	Single Arm

Primary Outcome Measures

Name	Time	Method
Types and incidence of complications	6 months post reconstruction	Documentaiton of any medical and/or surgical problem requiring treatment that arises as a result of the reconstruction procedure

Secondary Outcome Measures

Name	Time	Method
Aesthetic Outcomes	6 months post reconstruction	Aesthetic outcomes evaluated by the operating surgeon and two independent board certified plastic surgeons with breast reconstruction expertise
Patient-Reported Outcomes	6 months post reconstruction	Use of the Breast Q survey instrument

Trial Locations

Locations (2)

Liu Plastic surgery; 🇺🇸 Mountain View, California, United States

Liu Plastic Surgery; 🇺🇸 San Jose, California, United States