Monitoring Free Tissue Transfer Hemodynamics Using NIRS

NCT06661525 | Enrolling By Invitation DMC

• 1 other identifier: H22-03706
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Free tissue transfer (FTT) is a surgical procedure for repairing cancer resection wounds. Free tissue transfer usually involves taking skin from one area of the body (e.g. leg) and transplanting it to the surgically created wound (e.g. neck wound). Due to problems with anastomosis, the transplanted skin can die. If the poor blood supply can be detected early, transplanted skin can be saved by taking patients back to the operating room. The investigators propose to improve the design and test a novel, non-invasive monitoring system specifically for head and neck surgeries for early detection of poor blood supply to the transplanted tissue after FTT surgery.

Conditions

Oxygen Supply Absent

Keywords

NIRS Sensor; Tissue Oxygenation; Free Tissue Transfer (FTT)

Outcome Measures

Primary Outcomes (2)

• Establish a baseline Total Oxygenation Index (TOI) to measure NIRS on FTT cases

  The total oxygenation index (TOI) measurements will be used to establish a TOI baseline for Free Tissue Transfer (FTT) and to calibrate and tune the FTT-system

  Up to 36 months

• Enhance the design and accuracy of the FTT- NIRS sensor based on patient and clinicians feedback

  The data collected will be used to enhance the design and accuracy of the next generation of NIRS sensors based on the feedback provided by the patient and clinician

  24 months

Study Arms (2)

Participants

EXPERIMENTAL

Data collection from Participants and evaluate their feedback by filling a questioner

Device: Free Flap NIRS

Care providers

ACTIVE COMPARATOR

Care providers will provide their feedback via questioner

Device: Free Flap NIRS

Interventions

Free Flap NIRS DEVICE

Monitoring of tissue oxygenation after Free Tissue Transfer (FTT) surgeries.

Care providers; Participants

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients undergoing a variety of free tissue transfer for head and neck cancer. The result of the reconstruction should be easily visible to the clinicians.
• Age of 18 years old or older

You may not qualify if:

• Serious medical condition or other disease which occurs at the same time
• Metastatic disease
• Pregnant or nursing

Sponsors & Collaborators

• Surrey Memorial Hospital (SMH): collaborator
• Vancouver General Hospital: collaborator
• University of British Columbia: lead

Study Sites (2)

Surrey Memorial Hospital

Surrey, British Columbia, V3V 1Z2, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: October 28, 2024
• Study Start: April 20, 2025
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)