The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in transgender and non-binary patients undergoing gender affirming mastectomy. This study aims to understand a participant's experience of the device, including its usability and acceptability. Participants will use the device to precondition their right breast the evening before undergoing surgery (gender affirming mastectomy).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
15
Heat preconditioning
Division of Plastic & Reconstructive Surgery, Stanford University
Palo Alto, California, United States
RECRUITINGParticipant experience
Participants' experience of the device will be evaluated with the use of a questionnaire. Most of the questions will consist of multiple-choice components with a five-point scale and there will also be a section for further comments from participants.
Time frame: 30 days
Compliance
Proportion of participants who are compliant with the preconditioning protocol
Time frame: 1 day
Nipple necrosis/nipple graft loss
Proportion of participants experiencing partial or complete nipple necrosis/nipple graft loss and the rate of hospital readmission due to this
Time frame: 30 days
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