Monitoring System for Head and Neck Surgery

Recruiting 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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Free Flap NIRS?

Research shows that near-infrared spectroscopy (NIRS) is effective in monitoring free flaps after surgery by detecting changes in blood and oxygen levels, which helps identify problems early and improve the chances of successful recovery. ^{1 2 3 4 5}

Is the Monitoring System for Head and Neck Surgery using NIRS safe for humans?

The near-infrared spectroscopy (NIRS) system used for monitoring in surgeries is noninvasive, easy to use, and has been shown to be safe in humans. It helps detect problems early, improving the chances of successful recovery after surgery. ^{1 3 5 6 7}

How does the Free Flap NIRS treatment differ from other treatments for head and neck surgery?

The Free Flap NIRS treatment is unique because it uses near-infrared spectroscopy (NIRS) to monitor tissue oxygenation and blood flow in real-time during and after surgery. This allows for early detection of complications like blood vessel blockages, which can help prevent tissue damage and improve surgical outcomes. ^{5 7 8 9 10}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Free Flap Monitoring Using Near-Infrared Spectroscopy: A Systemic Review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Self-contained diffuse optical imaging system for real-time detection and localization of vascular occlusions. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Outcomes of free flap reconstructions with near-infrared spectroscopy (NIRS) monitoring: A systematic review. [2022]

4. China pubmed.ncbi.nlm.nih.gov

[Application of near-infrared spectroscopy to postoperative monitoring of flap in plastic surgery]. [2013]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A new protocol for improving immediate monitoring of skin-island free flap with near-infrared spectroscopy and ultrasound. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Three-year experience using near infrared spectroscopy tissue oximetry monitoring of free tissue transfers. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The use of near-infrared spectroscopy for assessing flap viability during reconstructive surgery. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Oxygenation and blood volume changes in flaps according to near-infrared spectrophotometry. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Design and testing of an optical instrument for skin flap monitoring. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Suprastomal cutaneous monitoring paddle for free flap reconstruction of laryngopharyngectomy defects. [2022]