Near Infrared Imaging and Flap Necrosis

NCT03476499 | Completed

• 1 other identifier: CAPCR ID:18-5013
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 2

Brief Summary

Skin flaps following mastectomy breast surgery that do not have enough oxygen are at risk for necrosis which can increase wound healing problems, postoperative recovery time and be costly to the hospital systems and affect the patient quality of life, poor esthetic results and overall reconstructive success. Mastectomy skin flap necrosis (MSFN) has an incidence of 10-15% with higher rates (7% - 30%) in mastectomy procedures with immediate reconstruction. Intraoperative assessment of the circulation in skin flaps is currently done with clinical assessment tools utilizing somewhat subjective identifiers such as flap color, capillary refill, temperature and dermal edge bleeding to determine the viability of the flap. Several technologies have been developed to assist in the clinical judgement of skin flaps but these technologies are not yet widely used because of the cost of the technology, the time required to image the patient, the intravenous injection of indocyanine green (ICG) dye required for contrast and the inability to image repeatedly and in different environments (pre-op, intra-op and post-op). A new commercially available imaging technology uses NIR spectroscopy to measure regional tissue hemoglobin oxygenation, using images that are taken 12 inches away from the patient. Preclinical data shows that NIR can predict necrosis in flaps but clinical data is needed to characterize and assess the value of the technology in plastic and reconstructive surgery. The purpose of this research study is to explore the ability of NIR imaging to predict skin flap tissue viability in the clinical setting of immediate breast reconstruction procedures. Study Design: This is a prospective, non-interventional study that will explore the ability of NIR imaging to predict of tissue viability in immediate breast reconstruction procedures. Necrosis will be scored using the SKIN score. Participation in the study will not impact patient care; all patients will receive standard care.

Conditions

Flap Necrosis

Outcome Measures

Primary Outcomes (1)

• Extent of mastectomy skin flap necrosis

  Partial/superficial necrosis and full-thickness necrosis as quantified by a SKIN score. These areas will be correlated with the intraoperative StO2 values from the NIR images.

  1 month

Secondary Outcomes (4)

• Infection

  1 month

• Wound Dehiscence or Implant Extrusion

  1 month

• Seroma/Hematoma

  1 month

• Removal or Loss of Implant

  1 month

Study Arms (1)

Planned skin flap procedure

EXPERIMENTAL

Inclusion Criteria: i. Planned skin flap procedure, ii. SpO2 above 96% and iii: Written informed consent. Exclusion criteria: Use of epinephrine, patent blue V or methelyne blue during procedure. The near infrared imaging NIR device is experimental. Experimental means that the NIR imaging is not used routinely in patients' care. The research will require no extra study visits. Images will be taken at 3 - 4 time points and a separate photo consent will be obtained prior to imaging. * One set of pre-procedure images, NIR images will be taken prior to the start of the breast surgery. * One set of intra-operative Images that will be taken intra-operatively following the mastectomy. * One to two follow-up sets of NIR images will be taken at the standard post-op follow-up visits at 1 to 2 weeks post-op for up to 30 days post-op. Follow-up visits will be scheduled as per the standard of care.

Device: Near Infrared Imaging (NIR) device

Interventions

Near Infrared Imaging (NIR) device DEVICE

Handheld near infrared multispectral imaging device with custom software.

Also known as: KENT CAMERA MULTISPECTRAL IMAGING DEVICE

Planned skin flap procedure

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• i. Planned skin flap procedure
• ii. SpO2 above 96%
• iii: Written informed consent.

You may not qualify if:

• Use of epinephrine, patent blue V or methelyne blue during procedure

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

Sinai Health System

Toronto, Ontario, M5G 1X5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Study Officials

• Stefan OP Hofer, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The physician taking the images will be blinded to the images until the end of the study.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: KENT CAMERA MULTISPECTRAL IMAGING DEVICE Health Canada Medical device Licence: 99281 First Issue Date: 2017/06/07 Device class 2 Handheld near infrared multispectral imaging device with custom software. A new commercially available imaging technology uses NIR spectroscopy to measure regional tissue hemoglobin oxygenation, StO2. These images are processed to produce a colour coded StO2 image of a large tissue area (\~6" by 4"). Since the image device doesn't contact the skin the depth of measurement is \~2mm instead of \~10mm with a point system. Compared to dye based angiography methods, StO2 NIR imaging does not require the injection of a dye. The advantage of the NIR imaging device over point NIR systems is a lack of patient contact. Thus StO2 NIR imaging is completely non-invasive, non-contact. Images can be captured and displayed in less than 5 seconds therefore imaging can be repeated as needed with no risk to the patient and no cost for disposables.

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: March 26, 2018
• Study Start: October 29, 2018
• Primary Completion: January 31, 2020
• Study Completion: February 29, 2020
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)