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Near Infrared Imaging and Flap Necrosis

NCT03476499 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2021-04-13

No results posted yet for this study

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

Interventions

DEVICE

Near Infrared Imaging (NIR) device

Handheld near infrared multispectral imaging device with custom software.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Stefan OP Hofer, PhD · University Health Network, Toronto

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-29
Primary Completion
2020-01-31
Completion
2020-02-29

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03476499 on ClinicalTrials.gov