Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03476499 |
| Other study ID # |
CAPCR ID:18-5013 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 29, 2018 |
| Est. completion date |
February 29, 2020 |
Study information
| Verified date |
April 2021 |
| Source |
University Health Network, Toronto |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Background of the study:
There are commercial medical devices that measure the spectrum of near infrared light
reflected from at a single location of tissue. These non-imaging devices are also called
point NIR spectroscopy devices. Point NIR spectroscopy devices have been used to monitor
blood perfusion to free flaps and mastectomy flaps. The unit of measurement is StO2; StO2 is
a measure of hemoglobin oxygen saturation weighted towards the saturation in the
microvascular bed as opposed to SaO2 or SvO2 which correspond to the arterial and venous
hemoglobin saturation respectively. StO2 is mixed arterial - venous measure of hemoglobin
oxygen saturation. Point devices use a light delivery and collection probe that needs to be
in contact with tissue. They can measure on the order of ~10mm deep over an area of
approximately 1cm by 1cm depending on the configuration of the device. Some studies using
point devices have shown significant differences in StO2 values in flaps that became necrotic
versus flaps that remained viable. NIR point systems however are not widely used
intraoperatively because they need to be brought in contact with the tissue being measured.
They also measure small areas thereby necessitating measurements over many spatially distinct
points on the flap to get a comprehensive measurement of flap oxygenation.
Rationale for this study A new commercially available imaging technology uses NIR
spectroscopy to measure regional tissue hemoglobin oxygenation, StO2. The device is based on
the same principles as point NIR spectroscopy devices but instead of contacting the skin a
set of images are taken 12 inches away from the patient. 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. 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.
Study hypotheses or research questions This study 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.
Primary objectives and secondary objectives:
Aim 1: To establish the NIR parameters that are consistent with flap viability. Aim 1: To
develop parameters to predict flap viability intraoperatively. Aim 3: To determine if NIR
values correspond to SKIN scores
Significance of the study The Innovation is a non-contact, non-invasive means to map/image
the oxygen available to an area of tissue. It requires no setup time and there are no
consumables associated with its measurement method. As cellular respiration in tissue
requires an adequate supply of oxygen, the tissue hemoglobin oxygen saturation image provided
by the Innovation can detect areas of tissue that are threatened by a poor oxygen supply. The
oxygenation measures provided by the device give surgeons insight into the healing potential
of skin flaps in procedures such as mastectomies. Skin flaps that are not sufficiently
oxygenated are at risk for necrosis which can be costly to the hospital systems and affect
the patient quality of life. The Innovation's oxygenation image assists surgeons in
identifying areas of flap ischemia intra-operatively and can be used to monitor flaps
post-operatively. With early identification of ischemic areas surgeons can intervene earlier
to reduce the risk of flap necrosis.
