NCT07516483

Brief Summary

The purpose of this research study is to understand patient experiences and the feasibility of using a breast heat preconditioning device (Plexaa BLOOM43), designed to improve postoperative outcomes when used prior to mastectomy and breast reconstruction.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026May 2027

First Submitted

Initial submission to the registry

March 20, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

July 30, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 20, 2026

Last Update Submit

July 29, 2026

Conditions

Breast Reconstruction After Mastectomy

Keywords

heat preconditioningmastectomybreast reconstruction

Outcome Measures

Primary Outcomes (5)

  • Recruitment Rate

    Percent of eligible patients who consent

    through week 2

  • Protocol Adherence Rate

    Percent of participants compliant with preconditioning as assigned

    through week 2

  • Interrater Reliability of Mastectomy Skin Flap Necrosis

    consistency of flap necrosis diagnosis across independent surgeons

    through week 2

  • Interrater Reliability of SKIN Score

    consistency of SKIN score across independent surgeons

    through week 2

  • Participant Feedback Survey Score

    Participants will be given an 11-item questionnaire with total score range 11-55 with lower scores indicating higher level of satisfaction.

    through week 2

Secondary Outcomes (9)

  • Incidence of Mastectomy Skin Flap Necrosis

    through week 2

  • Severity of Mastectomy Skin Flap Necrosis

    through week 2

  • Timing of Necrosis Onset

    through week 2

  • Number of Intraoperative Deviations

    through week 2

  • Number of Postoperative Wound Complications

    through week 2

  • +4 more secondary outcomes

Other Outcomes (4)

  • Data Completeness Rate

    through week 2

  • Blinding Success Rate

    through week 2

  • Use of Indocyanine Green Angiography

    through week 2

  • +1 more other outcomes

Study Arms (3)

3 Preconditioning Cycles

EXPERIMENTAL

three cycles of alternating between 30 minutes heating and 30 minutes spontaneous cooling to the breast 12 hours before operation.

Other: 3 Cycles Thermal Preconditioning

1 Preconditioning Cycle

EXPERIMENTAL

one cycle of alternating between 30 minutes heating and 30 minutes cooling in the preoperative area 1 hour before operation.

Other: 1 Cycle Thermal Preconditioning

Retrospective Group

ACTIVE COMPARATOR

retrospective chart review of patients meeting the same eligibility criteria who did not receive prospective interventions

Other: No Intervention

Interventions

1 Cycle Thermal PreconditioningOTHER

Thermal preconditioning with Plexaa BLOOM43 starting as close to 1 hour before the surgery as possible. Participants will keep the device on the breast for a total of 1 hour, allowing completion of one heating-cooling cycle before removing and turning off the device.

1 Preconditioning Cycle
No InterventionOTHER

participants did not receive intervention

Retrospective Group
3 Cycles Thermal PreconditioningOTHER

Thermal preconditioning with Plexaa BLOOM43 as close to 12 hours before the scheduled operation as possible. Participants will use the device as programmed, keeping it on the breast for a total of 3 hours.

3 Preconditioning Cycles

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (≥ 18 years of age) undergoing prophylactic or therapeutic mastectomy with planned immediate breast reconstruction at Atrium Health Wake Forest Baptist Medical Center.

You may not qualify if:

  • Patients with no plan for any breast reconstruction.
  • Patients with inflammatory breast cancer.
  • History of any radiation to the breast or chest wall.
  • Patients with pre-existing local dermatological conditions.
  • Patients belonging to vulnerable populations (e.g., children, pregnant individuals, incarcerated persons).
  • Patients unable to provide informed consent or comply with study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

  • Adam Katz, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caleb Suggs

CONTACT

3367134339caleb.suggs@advocatehealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2026

First Posted

April 8, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

July 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)