Plexaa For Preconditioning: Gender Affirming Mastectomy
Recruiting
N/A
Interventional Study
Nipple Necrosis
Nipple Graft Loss
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 15 (estimated)
- Sponsor
- Plexaa Ltd · Industry
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About This Trial
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 surge…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* All transgender or non-binary patients over the age of 18 years (no maximum age limit)
* Patients undergoing peri-areolar mastectomy or double incision mastectomy with a free nipple graft for gender affirmation
Exclusion Criteria:
* Patients undergoing surgery for breast can…
Contacts