Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Acellular Dermal Matrix (Cortiva Tissue Matrix)

    Device

    non-crosslinked dermis

Treatment groups

467 Participants
are divided into 2 treatment groups
Group A: Acellular Dermal MatrixExperimental treatment 1 intervention
Group B: no Acellular Dermal MatrixNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Rate of major adverse events

Surgery-related adverse events requiring rehospitalization or reoperation of the breast under study

Time frame
12 months
2

Health related quality of life

Change from baseline in quality of life as measured by the BREAST-Q Physical Well-Being

Time frame
12 months

Secondary outcomes

1

Change in quality of life

Change from baseline in quality of life as measured by the BREAST-Q

Time frame
1 year and 2 years
2

Procedure related adverse events

Rate of procedure-related adverse events requiring additional treatment

Time frame
3 months, 1 year and 2 years
3

Investigational device related adverse events

Rate of investigational device-related adverse events requiring additional treatment

Time frame
3 months, 1 year and 2 years
4

Histopathology assessment

Histopathology assessment at stage 2 procedure

Time frame
stage 2 procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RTI Surgical

Lead sponsor

MCRA

Collaborator

Source ClinicalTrials.gov
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