DIEP flap assessment and monitoring using continuous visible light spectrometry.

Not Applicable

• Conditions: Breast reconstruction surgery via DIEP flap reconstruction technique; Post-operational sleep quality; Breast Cancer; Surgery - Surgical techniques; Cancer - Breast

• Registration Number: ACTRN12624000183583
• Lead Sponsor: Chris O'Brien Lifehouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-02-26
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

1. Patient older than 18 years of age (no upper age limit)
2. Is about to undergo a DIEP flap reconstruction procedure (unilateral / bilateral) after diagnosis and treatment of breast cancer
3. Willing to provide consent and participate in the study, complying to all study requirements
4. Patients in the learning curve”

learning curve group is defined as the group of first few participants using the T-stat device. As the research team is using this new device for the first time and are adjusting to the usage of this device, results of these learning curve group may not be the optimal, but we are still including them in this study as this is a pilot study with a small sample size to test the feasibility of the device and looking at the possibility of expanding into a future large trial with a greater pool of patients.

Exclusion Criteria

1.Patients who are unable to read and write in English to a level required for consent and completion of questionnaires.
2.Patient who are or potentially may be allergic to the T-stat device sensor patch.
3.Patients whose skin, due to a named or unnamed condition, presents with non-clear fluid production that may interfere with the light signal.
4.Patients who have an existing sleep disorder (e.g sleep apnoea, insomnia, parasomnias, restless leg syndrome) which can interfere with their judgement of their post-operative sleep quality.
5.Patients who have an existing mental disorder (e.g depression, anxiety) which may interfere with their ability to provide accurate responses to the SF-36 and Breast Q questionnaires.

Study & Design

• Study Type: Interventional
• Study Design: Not specified