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Pilot Study Assessing Breast Temperature in Breast Cancer Patients

Pilot Study Assessing Cutaneous Breast Temperature in the Setting of Mastectomy and Reconstruction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03376035
Enrollment
52
Registered
2017-12-18
Start date
2017-12-05
Completion date
2019-01-07
Last updated
2019-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Reconstruction

Brief summary

Our investigators plan to measure the skin on the breast six months after breast reconstruction. The non-reconstructed breast will be used as the control for subject with unilateral reconstruction only. For those who have BILATERAL reconstruction, a core temperature will be obtained from the ear.

Detailed description

Many factors influence outcomes following mastectomy and breast reconstruction. Cutaneous sensation, degree of scar formation, nipple projection and overall appearance are well correlated with patient satisfaction. However, very little data exists on the importance of skin temperature after mastectomy and reconstruction. Our investigators have noted that a number of patients report their reconstructed breast is cold and relate this as a source of dis-satisfaction. In these patients, it is unclear if 1) the reconstructed breast skin is cold and if so 2) can something can be done to improve this. Our investigators hypothesize that cutaneous breast temperature may be altered after mastectomy and reconstruction. This may be dependent on the reconstruction technique and other patient factors. In this pilot study, our investigators aim to establish techniques for evaluating cutaneous breast temperature following mastectomy and reconstruction. Our investigators hope to establish baseline data to develop an understanding of breast skin temperature after mastectomy and reconstruction. Our long-term goals are to evaluate how cutaneous breast temperature may contribute to patient satisfaction. Our investigators also hope to determine which patients are at risk for developing a cold breast after surgery. Finally, our investigators will setup a prospective trial evaluating techniques to correct this problem and improve patient satisfaction.

Interventions

OTHERTemperature measurement of breast

Multiple measurements will be obtained from the ear, chest, breast, abdomen, and hands.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Determine skin temperature after breast reconstruction

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* For post-reconstruction patients: all patients who have undergone mastectomy and breast reconstruction at Duke and are seen in clinic no sooner than 3 months after reconstruction and no more than 5 years after reconstruction.

Exclusion criteria

* Metastatic malignancy of any kind. * Subjects with a history of breast implant augmentation prior to mastectomy and reconstruction. * Subjects who cannot give an informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Change in skin temperature after breast reconstruction6 months after surgeryTemperature measurements

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026