Clinical trial NCT06502353: Plexaa For Preconditioning: Gender Affirming Mastectomy
Official title: A Pilot Study to Investigate the Use of the Plexaa Preconditioning Device (BLOOM43) for Gender Affirming Mastectomy - a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nipple Necrosis
Nipple Graft Loss
Keywords: Nipple necrosis
Nipple graft loss
Preconditioning
Lead sponsor: Plexaa Ltd
Sponsor class: INDUSTRY
Collaborators: name: Stanford University
First posted: 2024-07-16
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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: 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

Primary outcomes:
measure: Participant experience
timeFrame: 30 days
Secondary outcomes:
measure: Compliance
timeFrame: 1 day
measure: Nipple necrosis/nipple graft loss
timeFrame: 30 days
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Division of Plastic & Reconstructive Surgery, Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Dung Nguyen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.