Plexaa For Preconditioning: Gender Affirming Mastectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BLOOM43.
- Who it may be relevant to
- Registry conditions: Nipple Necrosis, Nipple Graft Loss. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Study to Investigate the Use of the Plexaa Preconditioning Device (BLOOM43) for Gender Affirming Mastectomy - a Prospective Cohort Study
Overview
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).
Interventions
- Device BLOOM43
Heat preconditioning
Primary outcome measures
- Participant experience [Time frame: 30 days]
Secondary outcome measures (2)
- Compliance [Time frame: 1 day]
- Nipple necrosis/nipple graft loss [Time frame: 30 days]
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 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
- Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Division of Plastic & Reconstructive Surgery, Stanford University — Palo Alto
Publications
- Meerwijk EL, Sevelius JM. Transgender Population Size in the United States: a Meta-Regression of Population-Based Probability Samples. Am J Public Health. 2017 Feb;107(2):e1-e8. doi: 10.2105/AJPH.2016.303578. PMID 28075632
- Rifkin WJ, Robinson IS, Kloer C, Cripps CN, Boyd CJ, Blasdel G, Zhao LC, Bluebond-Langner R. Gender-affirming Mastectomy: Comparison of Periareolar and Double Incision Patterns. Plast Reconstr Surg Glob Open. 2022 May 25;10(5):e4356. doi: 10.1097/GOX.0000000000004356. eCollection 2022 May. PMID 35646495
- Perez-Alvarez IM, Zolper EG, Schwitzer J, Fan KL, Del Corral GA. Incidence of Complications in Chest Wall Masculinization for the Obese Female-to-Male Transgender Population: A Case Series. World J Plast Surg. 2021 May;10(2):14-24. doi: 10.29252/wjps.10.2.14. PMID 34307093
- Kankam HKN, Mehta S, Jain A. Thermal Preconditioning for Surgery: A Systematic Review. J Plast Reconstr Aesthet Surg. 2020 Sep;73(9):1645-1664. doi: 10.1016/j.bjps.2020.05.025. Epub 2020 May 21. PMID 32505626
- Mehta S, Rolph R, Cornelius V, Harder Y, Farhadi J. Local heat preconditioning in skin sparing mastectomy: a pilot study. J Plast Reconstr Aesthet Surg. 2013 Dec;66(12):1676-82. doi: 10.1016/j.bjps.2013.07.034. Epub 2013 Sep 4. PMID 24011908
- Mehta S, Cro SC, Coomber B, Rolph R, Cornelius V, Farhadi J. A randomised controlled feasibility trial to evaluate local heat preconditioning on wound healing after reconstructive breast surgery: the preHEAT trial. Pilot Feasibility Stud. 2019 Jan 11;5:5. doi: 10.1186/s40814-019-0392-y. eCollection 2019. PMID 30656059
Identifiers
NCT: NCT06502353 · 75139 · Pro00074534