NCT03376035

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 5, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

December 5, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2019

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

1.1 years

First QC Date

December 5, 2017

Last Update Submit

January 7, 2019

Conditions

Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

  • Change in skin temperature after breast reconstruction

    Temperature measurements

    6 months after surgery

Study Arms (2)

Unilateral breast reconstruction

ACTIVE COMPARATOR

Temperature measurements are obtained from the reconstructed breast and compared to the non-reconstructed breast.

Other: Temperature measurement of breast

Bilateral breast reconstruction

EXPERIMENTAL

Temperature measurements are obtained from both reconstructed breasts and the core temperature is measured as well for comparison.

Other: Temperature measurement of breast

Interventions

Temperature measurement of breastOTHER

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

Bilateral breast reconstructionUnilateral breast reconstruction

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27708, United States

Location

Study Officials

  • Scott Hollenbeck, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Determine skin temperature after breast reconstruction
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2017

First Posted

December 18, 2017

Study Start

December 5, 2017

Primary Completion

January 7, 2019

Study Completion

January 7, 2019

Last Updated

January 8, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)