Breast Reconstruction After MastectomyNCT07516483
Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction
A study testing 1 Cycle Thermal Preconditioning and 3 Cycles Thermal Preconditioning in people with Breast Reconstruction After Mastectomy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Reconstruction After Mastectomy
- What is being tested?
- 1 Cycle Thermal Preconditioning and 3 Cycles Thermal Preconditioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥ 18 years of age) undergoing prophylactic or therapeutic mastectomy with planned immediate breast reconstruction at Atrium Health Wake Forest Baptist Medical Center.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Thermal Preconditioning in Patients Undergoing Mastectomy With Planned Immediate Breast Reconstruction: A Randomized Feasibility Trial
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.
Read the detailed description
This study will be a prospective, single-center, two-arm randomized trial comparing two preconditioning interventions, with a separate retrospective cohort serving as the standard of care control group without preconditioning. For the prospective component, eligible patients undergoing mastectomy with preoperative plan of undergoing immediate autologous or device-based breast reconstruction at the Atrium Health Wake Forest Baptist Medical Center will be randomized in a 1:1 ratio into a 3-cycle or 1-cycle treatment group. There will also be a retrospective chart review to create a control group.
- Conditions
- Breast Reconstruction After Mastectomy
- Being tested
- 1 Cycle Thermal Preconditioning, 3 Cycles Thermal Preconditioning, No Intervention
- Keywords
- heat preconditioning, mastectomy, breast reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
No InterventionOther
participants did not receive intervention
| Study group | Role | What they receive |
|---|---|---|
| 3 Preconditioning Cycles | Experimental | three cycles of alternating between 30 minutes heating and 30 minutes spontaneous cooling to the breast 12 hours before operation. Receives: 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. Receives: 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 Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Percent of eligible patients who consent
Measured: through week 2
Protocol Adherence Rate
Percent of participants compliant with preconditioning as assigned
Measured: through week 2
Interrater Reliability of Mastectomy Skin Flap Necrosis
consistency of flap necrosis diagnosis across independent surgeons
Measured: through week 2
Interrater Reliability of SKIN Score
consistency of SKIN score across independent surgeons
Measured: 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.
Measured: through week 2
Secondary outcomes (9)
Incidence of Mastectomy Skin Flap Necrosis
number of participants with mastectomy skin flap necrosis
Measured: through week 2
Severity of Mastectomy Skin Flap Necrosis
severity of mastectomy skin flap necrosis measured by SKIN score
Measured: through week 2
Timing of Necrosis Onset
number of days until onset of postoperative necrosis
Measured: through week 2
Number of Intraoperative Deviations
Number of intraoperative deviation from planned reconstruction (e.g. aborted immediate reconstruction, expander deflation, closure over drains)
Measured: through week 2
Number of Postoperative Wound Complications
Number of participants with postoperative wound complications (e.g., infection, incision dehiscence, flap erosion, expander exposure)
Measured: through week 2
Number of Expander Failures
Number of participants with expander failure defined as explantation, loss, or non-use due to flap compromise
Measured: through week 2
Number of Returns to the Operating Room
Number of participants that returned to the Operating Room due to necrosis or related complications
Measured: through week 2
Length of Hospital Stay
number of days participants spent admitted to the hospital
Measured: through week 2
Length of Follow Up
number of weeks participants were followed post discharge
Measured: through week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Reconstruction After MastectomyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Katz, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516483
- Sponsor's protocol ID
- IRB00146716
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Preconditioning in Patients Undergoing Mastectomy With Planned Immediate Breast Reconstruction: A Randomized Feasibility Trial
- ClinicalTrials.gov ID
- NCT07516483
- Acronym / sponsor ID
- IRB00146716
- Conditions
- Breast Reconstruction After Mastectomy
- Keywords
- heat preconditioning, mastectomy, breast reconstruction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be a prospective, single-center, two-arm randomized trial comparing two preconditioning interventions, with a separate retrospective cohort serving as the standard of care control group without preconditioning. For the prospective component, eligible patients undergoing mastectomy with preoperative plan of undergoing immediate autologous or device-based breast reconstruction at the Atrium Health Wake Forest Baptist Medical Center will be randomized in a 1:1 ratio into a 3-cycle or 1-cycle treatment group. There will also be a retrospective chart review to create a control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 Preconditioning Cycles | Experimental | Other: 3 Cycles Thermal Preconditioningthree cycles of alternating between 30 minutes heating and 30 minutes spontaneous cooling to the breast 12 hours before operation. |
| 1 Preconditioning Cycle | Experimental | Other: 1 Cycle Thermal Preconditioningone cycle of alternating between 30 minutes heating and 30 minutes cooling in the preoperative area 1 hour before operation. |
| Retrospective Group | Active comparator | Other: No Interventionretrospective chart review of patients meeting the same eligibility criteria who did not receive prospective interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (≥ 18 years of age) undergoing prophylactic or therapeutic mastectomy with planned immediate breast reconstruction at Atrium Health Wake Forest Baptist Medical Center.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 Cycle Thermal PreconditioningThermal 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. | Other | 1 Preconditioning Cycle |
| 3 Cycles Thermal PreconditioningThermal 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. | Other | 3 Preconditioning Cycles |
| No Interventionparticipants did not receive intervention | Other | Retrospective Group |
Primary outcome
Recruitment Rate
Time frame: through week 2
Percent of eligible patients who consent
Protocol Adherence Rate
Time frame: through week 2
Percent of participants compliant with preconditioning as assigned
Interrater Reliability of Mastectomy Skin Flap Necrosis
Time frame: through week 2
consistency of flap necrosis diagnosis across independent surgeons
Interrater Reliability of SKIN Score
Time frame: through week 2
consistency of SKIN score across independent surgeons
Participant Feedback Survey Score
Time frame: through week 2
Participants will be given an 11-item questionnaire with total score range 11-55 with lower scores indicating higher level of satisfaction.
9 secondary outcomes
Incidence of Mastectomy Skin Flap Necrosis
Time frame: through week 2
Severity of Mastectomy Skin Flap Necrosis
Time frame: through week 2
Timing of Necrosis Onset
Time frame: through week 2
Number of Intraoperative Deviations
Time frame: through week 2
Number of Postoperative Wound Complications
Time frame: through week 2
Number of Expander Failures
Time frame: through week 2
Number of Returns to the Operating Room
Time frame: through week 2
Length of Hospital Stay
Time frame: through week 2
Length of Follow Up
Time frame: through week 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Reconstruction After Mastectomy
Not yet recruiting
Synthetic Electrospun Fiber Matrix in Abdominal Wall Donor Sites for Breast Reconstruction
Breast Reconstruction, Deep Inferior Epigastric Perforator
Recruiting
Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients
Breast Cancer, Breast Reconstruction
Not yet recruitingObservational study
A Comparative Study of Delayed Endoscopic DTI and Autologous Flap Reconstruction Post-Mastectomy
Breast Reconstruction After Mastectomy
RecruitingObservational study
Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Breast Reconstruction, Breast Reconstruction Following Mastectomy
Active, not recruiting
A Study on Pain After Breast Reconstruction
Mastectomy, Mastectomy Patient
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam Katz, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 Cycle Thermal Preconditioning and 3 Cycles Thermal Preconditioning in people with Breast Reconstruction After Mastectomy, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caleb Suggs (3367134339, caleb.suggs@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: through week 2). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.