Health TrialsbyHealthPanel

Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction

ConditionBreast Reconstruction After Mastectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 1 Cycle Thermal Preconditioning

    Other intervention

    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 Preconditioning

    Other intervention

    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 Intervention

    Other intervention

    participants did not receive intervention

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: 3 Preconditioning CyclesExperimental treatment 1 intervention
Group B: 1 Preconditioning CycleExperimental treatment 1 intervention
Group C: Retrospective GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment Rate

Percent of eligible patients who consent

Time frame
through week 2
2

Protocol Adherence Rate

Percent of participants compliant with preconditioning as assigned

Time frame
through week 2
3

Interrater Reliability of Mastectomy Skin Flap Necrosis

consistency of flap necrosis diagnosis across independent surgeons

Time frame
through week 2
4

Interrater Reliability of SKIN Score

consistency of SKIN score across independent surgeons

Time frame
through week 2

Secondary outcomes

1

Incidence of Mastectomy Skin Flap Necrosis

number of participants with mastectomy skin flap necrosis

Time frame
through week 2
2

Severity of Mastectomy Skin Flap Necrosis

severity of mastectomy skin flap necrosis measured by SKIN score

Time frame
through week 2
3

Timing of Necrosis Onset

number of days until onset of postoperative necrosis

Time frame
through week 2
4

Number of Intraoperative Deviations

Number of intraoperative deviation from planned reconstruction (e.g. aborted immediate reconstruction, expander deflation, closure over drains)

Time frame
through week 2

Other outcomes

1

Data Completeness Rate

Percent of planned outcome data collected

Time frame
through week 2
2

Blinding Success Rate

number of surgeons that remained unaware of allocation during image-based diagnosis and grading of necrosis

Time frame
through week 2
3

Use of Indocyanine Green Angiography

number of surgeons that used indocyanine green angiography

Time frame
through week 2
4

Change from preoperative plan to final operation

number of surgeons that changed their preoperative plan before the final operation

Time frame
through week 2

Sponsors and contacts

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

Wake Forest University Health Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: