Health TrialsbyHealthPanel

Plexaa For Preconditioning: Gender Affirming Mastectomy

ConditionsNipple NecrosisNipple Graft Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPlexaa Ltd

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 surgery (gender affirming mastectomy).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients undergoing surgery for breast cancer

Delayed (two-stage) breast reconstruction patients

Patients undergoing simple mastectomy or wide local excision of a breast tumour

Presence of open breast skin wounds, or infected or inflamed breast skin

Trial design

Design model

Single group

Treatments tested in this trial

  • BLOOM43

    Device

    Heat preconditioning

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: All participants (single arm)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Participant 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

Secondary outcomes

1

Compliance

Proportion of participants who are compliant with the preconditioning protocol

Time frame
1 day
2

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

Other outcomes

Sponsors and contacts

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

Plexaa Ltd

Lead sponsor

Stanford University

Collaborator

Source ClinicalTrials.gov
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