Monitoring System for Head and Neck Surgery

Enrolling by invitation at 1 trial location

Overseen By Amir Rad, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Serious condition, Metastatic disease, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new non-invasive monitoring system, Free Flap NIRS, to detect early signs of poor blood supply in transplanted skin after head and neck cancer surgeries. The goal is to save the transplanted tissue by identifying issues early, allowing doctors to act quickly. Participants will include patients who have undergone free tissue transfer surgeries for head and neck cancer. Patients whose surgical reconstruction is easily visible to doctors might be suitable candidates. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance post-surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this monitoring system is safe for head and neck surgeries?

Research has shown that using Near-Infrared Spectroscopy (NIRS) during free flap surgeries is promising for safety. In studies, NIRS identified blood flow problems in the moved tissue, increasing the chances of saving it. Specifically, when NIRS detected blood flow issues, the tissue was saved 89% of the time, compared to only 50% without NIRS. This indicates that NIRS can help catch problems early and possibly prevent complications.

A review of 221 surgeries found that the NIRS system automatically detected blood flow issues in about 22% of cases. While complications can still occur, NIRS seems to provide an early warning system to address them sooner. This suggests that the NIRS method is generally safe and well-tolerated for patients undergoing these procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Monitoring System for Head and Neck Surgery trial because it explores the use of Free Flap NIRS (Near-Infrared Spectroscopy) to improve surgical outcomes. Unlike traditional monitoring methods, which often rely on visual inspection and manual assessments, NIRS offers a non-invasive way to continuously monitor blood flow in real-time. This technique provides immediate feedback, potentially allowing for quicker interventions and reducing the risk of complications. By capturing detailed data from both participants and care providers, this trial aims to refine surgical techniques and enhance recovery processes for patients undergoing complex head and neck surgeries.

What evidence suggests that this monitoring system is effective for detecting poor blood supply in head and neck surgeries?

Research has shown that using Near-Infrared Spectroscopy (NIRS) to monitor free tissue transfers (FTT) greatly increases the chances of saving tissue with blood flow problems. In one study, tissue flaps with blood flow issues achieved an 89% success rate when monitored with NIRS, compared to only 50% without it. Another study found that flaps monitored with NIRS had a slightly better overall survival rate of 98.1%, compared to 96.3% with traditional methods. This evidence suggests that NIRS effectively detects blood supply problems early, leading to better outcomes for patients undergoing head and neck surgery. Participants in this trial will be monitored using the Free Flap NIRS system to evaluate its effectiveness in a clinical setting. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients undergoing free tissue transfer (FTT) surgery, typically after cancer resection. It's aimed at those who need to repair wounds by transplanting skin from one body part to another.

Inclusion Criteria

I am one of 60 patients getting tissue transfer surgery for head and neck cancer that results in visible changes.

Exclusion Criteria

Pregnant or nursing

My cancer has spread to other parts of my body.

I have a serious health condition besides my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intra-operative Monitoring

NIRS measurements are collected during a single FTT operation to simulate FTT compromise

Single operation

Post-operative Monitoring

NIRS probe is placed and fixed over the FTT for 72 hours to monitor vascular status

72 hours

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Free Flap NIRS

Trial Overview The study tests a new non-invasive system using Near-Infrared Spectroscopy (NIRS) to monitor blood supply in transplanted tissue during head and neck surgeries. The goal is early detection of poor blood flow which can lead to tissue death if not addressed promptly.

How Is the Trial Designed?

Group I: Participants Experimental Treatment 1 Intervention

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

Group II: Care providers Active Control 1 Intervention

Care providers will provide their feedback via questioner

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Surrey Memorial Hospital (SMH)

Collaborator

Trials

1

Recruited

60+

Vancouver General Hospital

Collaborator

Trials

42

Recruited

19,700+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31664735/

Outcomes of Free Flap Reconstructions With Near-Infrared ... Overall, flaps with vascular compromise monitored with NIRS had a significantly higher salvage rate of 89% compared with a salvage rate of 50% in the flaps ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2096691122000462

Current evidence on the use of near-infrared spectroscopy ... The overall survival rate for flaps monitored with CM and NIRS (98.1%) was also significantly higher than that for flaps monitored with CM alone (96.3%) (P=0.02) ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/micr.30526

Outcomes of free flap reconstructions with near‐infrared ... Overall, flaps with vascular compromise monitored with NIRS had a significantly higher salvage rate of 89% compared with a salvage rate of 50% ...

4. jprasurg.com jprasurg.com/article/S1748-6815(23)00182-1/abstract

A new protocol for improving immediate monitoring of skin- ... A total of 221 free flaps performed in 209 patients were included. The NIRS automatically detected vascular compromise in 21.8% of cases. A ...

5. researchgate.net researchgate.net/publication/336902183_Outcomes_of_free_flap_reconstructions_with_near-infrared_spectroscopy_NIRS_monitoring_A_systematic_review

Outcomes of free flap reconstructions with near-infrared ... Overall, flaps with vascular compromise monitored with NIRS had a significantly higher salvage rate of 89% compared with a salvage rate of 50% in the flaps ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/micr.30526

Outcomes of free flap reconstructions with near‐infrared ... Overall, flaps with vascular compromise monitored with NIRS had a significantly higher salvage rate of 89% compared with a salvage rate of 50% ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681523001821

New Protocol for Improving Skin-Island Free Flap Monitoring A total of 221 free flaps performed in 209 patients were included. The NIRS automatically detected vascular compromise in 21.8% of cases. A complication was ...

8. nature.com nature.com/articles/s41598-025-15300-5

Machine learning approaches overcome imbalanced ... Free flap reconstruction is essential for treating intraoral defects; however, failure can lead to complex and prolonged complications.

9. medicaljournalssweden.se medicaljournalssweden.se/JPHS/article/view/7140

Diagnostical accuracy of hyperspectral imaging after free ... Microsurgical tissue transfer success rate was 84%. Seven patients presented with venous congestion that caused total flap necrosis. Overall, ...