Health Trials

Acellular Dermal Matrix Investigation in Breast Reconstruction

ConditionBreast Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22+
SponsorRTI Surgical

About this trial

Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.

Eligibility criteria

Qualifiers

Genetic female

Age 22 or older at time of consent

Undergoing immediate breast reconstruction

2 stage breast reconstruction using pre pectoral technique

Disqualifiers

Planned concurrent reconstruction with pedicled flaps or free tissue

Pregnant or breast feeding

Investigator has determined tissue is unsuitable for two-stage breast reconstruction

History of psychological characteristics that may be incompatible with the surgical procedure and the prosthesis

Trial design

Treatments tested in this trial

  • Acellular Dermal Matrix (Cortiva Tissue Matrix)

Treatment groups

467 Participants
are divided into 2 treatment groups

Locations

13
Arkansas
University of Arkansas72205, Little Rock United States
California
City of Hope National Medical Center91010, Duarte United States
Colorado
University of Colorado80045, Aurora United States
Kansas
University of Kansas66045, Lawrence United States

Sponsors and collaborators

RTI Surgical

Lead sponsor

MCRA

Collaborator

Source ClinicalTrials.gov