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Wearn 2017
Wearn 2017
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Christopher Wearn a,b,1 , Kwang Chear Lee a,b,1 , Joseph Hardwicke a,b ,
Ammar Allouni a , Amy Bamford a, Peter Nightingale c ,
Naiem Moiemen a,b, *
a
Scar Free Foundation Centre for Burns Research, University Hospital Birmingham NHS Foundation Trust, Queen
Elizabeth Hospital Birmingham, Mindelsohn Way, Edgbaston, Birmingham B15 2WB, UK
b
University of Birmingham, Edgbaston, Birmingham B15 2TT, UK
c
Wellcome Trust Clinical Research Facility Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Edgbaston,
Birmingham B15 2WB, UK
Article history: Introduction: The accurate assessment of burn depth is challenging but crucial for surgical
Accepted 9 August 2017 excision and tissue preservation. Laser Doppler Imaging (LDI) has gained increasing
Available online xxx acceptance as a tool to aid depth assessment but its adoption is hampered by high costs, long
scan times and limited portability. Thermal imaging is touted as a suitable alternative
however few comparison studies have been done.
Keywords:
Methods: Sixteen burn patients with 52 regions of interests were analysed. Burn depth was
Burn depth
determined using four methods LDI, thermal imaging, photographic and real-time clinical
Thermal imaging
evaluation at day 1 and day 3. LDI flux and Delta T values were used for the prediction of
Laser Doppler Imaging
outcomes (wound closure in <21 days). Photographic clinical evaluation of burn depth was
Clinical assessment
performed by 4 blinded burn surgeons.
Results: Accuracy of assessment methods were greater on post burn day 3 compared to day 0.
Accuracies of LDI on post burn day 0 and 3 were 80.8% and 92.3% compared to 55.8% and 71.2%
for thermal imaging and 62.5% and 71.6% for photographic clinical assessment. Real-time
clinical examination had an accuracy of 88.5%. Thermal imaging scan times were
significantly faster compared to LDI.
Discussion: LDI outperforms thermal imaging in terms of diagnostic accuracy of burn depth
likely due to the susceptibility of thermal imaging to environmental factors.
Crown Copyright © 2017 Published by Elsevier Ltd. All rights reserved.
* Corresponding author at: Scar Free Foundation Centre for Burns Research, University Hospital Birmingham NHS Foundation Trust, Queen
Elizabeth Hospital Birmingham, Mindelsohn Way, Edgbaston, Birmingham B15 2WB, UK.
E-mail addresses: nmoiemen@aol.com, naiem.moiemen@uhb.nhs.uk (N. Moiemen).
1
Joint first authors.
http://dx.doi.org/10.1016/j.burns.2017.08.004
0305-4179/Crown Copyright © 2017 Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: C. Wearn, et al., Prospective comparative evaluation study of Laser Doppler Imaging and thermal
imaging in the assessment of burn depth, Burns (2017), http://dx.doi.org/10.1016/j.burns.2017.08.004
JBUR 5341 No. of Pages 10
The accurate assessment of burn depth is a critical step in the 2.1. Patient selection
management of the burn injured patient, with a key decision
being whether a wound will benefit from surgical manage- Adult patients admitted to the Birmingham Burns Centre,
ment. The depth of the burn injury is a key determinant of University Hospitals NHS Foundation Trust between were
wound healing time and a relationship between the time to screened for eligibility for prospective recruitment into the
wound closure and the incidence of hypertrophic scarring study over a 12 month period from May 2012. The study
(HTS) has been clinically demonstrated [1]. Establishing the included adults aged 18 years and above presenting within 24h
difference between superficial dermal burns that will heal of an acute burn injury <15% of Total body surface area.
spontaneously within 21days and deep dermal burns which Detailed inclusion and exclusion criteria can be seen in Table 1
can result in longer healing time and associated pathological and Fig. 1. Burn wounds overlying skin tattoos were not
scarring is challenging, even for experienced burn surgeons [2– included due to reflectance artifact. The study protocol
4]. Burn depth classification via visual interpretation has received approval by an NHS Research Ethics Committee
remained relatively unchanged since the 16th century [5], (REC reference: 12/SW/0028).
however in the last few decades the increasing use of
technology to aid the assessment of burn depth and the 2.2. Study protocol
progression of the burn wound has allowed earlier diagnosis of
burns that may benefit from excision, and tissue preservation Patients enrolled into the study underwent study visits for
of those that will heal spontaneously. burn depth assessment on day 1 (within 24h after-injury);
Douglas Jackson, at the Birmingham Accident Hospital, again on day 3 (at 48–96h after-injury) and wound healing
was the first to identify a link between progression of the evaluation on Day 14; and Day 21 if not fully healed at Day 14.
clinical depth of the burn wound and the dermal microvas- Burn depth estimation was performed by four methods: (1)
cular blood flow [6]. The link between burn depth and blood Laser Doppler Imaging (LDI) with a Moor LDI2-B1 (Moor
flow in the superficial vascular plexus inspired the develop- Instruments, Axmoor, UK); (2) Thermographic imaging with
ment of a number of technologies to measure this, either the FLIR SC660 thermal imaging camera (FLIR Systems, Inc.,
directly or indirectly. Laser Doppler Imaging (LDI) utilizes a Wilsonville, USA); (3) Clinical assessment with 2D photogra-
623nm red diode laser, which superficially penetrates the phy; and (4) Real-time clinical assessment. Two dimensional
skin and is reflected by circulating erythrocytes in the dermal (2D) clinical photography was undertaken at all visits using a
vasculature. A transducer measures the Doppler shift in light Nikon D300S DSLR camera (Nikon Corporation, Tokyo, Japan)
frequency from the erythrocytes moving relative to the laser by the clinical photography team and these photographs were
source and provides a semi-quantitative measure of perfu- then assessed by four consultant burn surgeons blinded to the
sion. LDI has now been validated in a large multi-centre outcomes. Real-time clinical assessment at the time of
study over of over 400 burn wounds and shown to have a presentation (day 0) by the on-call consultant was collected
technical accuracy of 96% in predicting whether wounds will retrospectively. Decisions on need for surgical excision and
be healed by 21 days [7,8]. The National Institute for Clinical skin grafting were made on clinical grounds in obviously full
Excellence (NICE) in the UK recommends the use of LDI in thickness or deep dermal burns; LDI was used to assist
addition to clinical assessment for clinically indeterminate decision-making in the case of clinically indeterminate burn
burn wounds [9]. wounds. Cases which were found to have a significant area
Thermal imaging provides an indirect measure of cutane- with a healing potential of >21days underwent excision and
ous blood flow and was originally described by Lawson in 1961, skin grafting, in line with the standard of care prior to
to accurately predict the depth of burns in dogs [10]. Mladick commencement of the study. If the patient had multiple
et al. in 1966 found that thermograms correlated very closely separate burn wounds, all were included as study wounds and
with the pattern of depth of the burn injuries in patients [11]
and later, Hackett concluded that clinical examination of the
burn failed to predict depth in one third of cases compared to
10% failure with thermal imaging [12]. Hardwicke et al. Table 1 – Inclusion and exclusion criteria for study.
conducted a pilot evaluation study at our centre utilizing a Inclusion criteria Exclusion criteria
current generation high resolution real time thermal imaging
Adults (18–99 years) Children (<18years)
camera and found that it could differentiate between clinically
Within 24h of burn Unable or refusal to give informed
full thickness, deep partial thickness and superficial partial
injury consent
thickness burns based on temperature comparisons with non- <15% TBSA Suspected burn wound
burnt skin [13]. The images were high resolution and could be infection/cellulitis
acquired rapidly suggesting potential advantages over other All burn depths Chemical burns
imaging modalities such as LDI. We therefore conducted a Incomplete images at day 0 and 3
comparative evaluation study to compare the accuracy of Excised and grafted before day 21
Skin tattoos
high-resolution digital thermal imaging with the current gold
Participation in other interventional
standard, LDI, in assessing wound healing potential in adult trials
burn injured patients.
Please cite this article in press as: C. Wearn, et al., Prospective comparative evaluation study of Laser Doppler Imaging and thermal
imaging in the assessment of burn depth, Burns (2017), http://dx.doi.org/10.1016/j.burns.2017.08.004
JBUR 5341 No. of Pages 10
Fig. 1 – CONSORT diagram for the study detailing the number of patients enrolled, excluded from study, and final number
included for analysis.
allocated an identification number. All LDI and thermal Germany). For comparison with the burn wound temperature,
imaging were performed either in a designated clinical a control area of non-burnt skin, where possible on the contra-
assessment room or in the patient’s own room. Ambient lateral side, was thermally imaged. If this was not possible (due
temperature was standardised to 23 C and humidity was to multiple burn sites,), an area of non-burnt skin adjacent to
measured consistently to be around 50%. The LDI and thermal the burn wound was used.
images were then uploaded and analysed objectively at the Image analysis was performed using the FLIR Thermal
completion of the trial, using their respective software (see researcher Pro V4.0 software (FLIR Systems, Inc., Wilsonville,
below). Prior to wound assessment and scanning, burn USA). Based on the previous work of Hackett [16], the burn
wounds were checked to ensure adequate cleaning and depth diagnosis was determined by the difference between the
debridement and absence of dressing residues. The scanning mean temperature of the burn wound and the mean
times were recorded for each method using a stopwatch and a temperature of the control area of non-burnt skin [17] (Delta
patient satisfaction questionnaire was given to each patient T, DT) (Table 2). A full thickness or deep dermal depth burn was
after the first two study visits. considered to have a healing potential (HP) of >21days and a
superficial partial thickness burn a HP of <21 days.
2.3. Thermal imaging
2.4. LDI scanning
Static thermographic images were recorded at a distance of
70cm. For the purposes of standardization, skin cooling [14] The study team performed all scans, each trained, assessed
and occlusive dressings [15] were not used. The base and deemed competent in the use of LDI by the manufacturer.
temperature was adjusted to 30 C and the peak temperature Images were acquired at a distance of 70cm from the burn
adjusted to the patient’s core temperature, as measured by wound. Image analysis was performed using the Moor LDI2-BI
1
tympanic thermometer (Braun Thermoscan , Braun GmbH, V2 software (Moor Instruments, Axmoor, UK). Mean LDI flux
Table 2 – Determination of burn depth diagnosis from static thermal imaging according to criteria used by Hackett15.
DT=Mean temperature of non-burnt skin (TC) — mean temperature of burn wound (TB).
DT value ( C) Burn depth interpretation Healing potential (HP) (days)
<1.5 Superficial partial thickness (SPT) <21
1.5 and <2.5 Deep dermal (DD)/deep partial thickness (DPT) >21
2.5 Full thickness (FT) >21
Please cite this article in press as: C. Wearn, et al., Prospective comparative evaluation study of Laser Doppler Imaging and thermal
imaging in the assessment of burn depth, Burns (2017), http://dx.doi.org/10.1016/j.burns.2017.08.004
JBUR 5341 No. of Pages 10
Table 3 – Validated LDI colour palette and healing easier to grade and what features of the wound guided them
potential for each flux range. PU=Perfusion units. to make their decisions.
LDI Flux value LDI palette Healing potential (HP)
(PU) colour (days) 2.6. Real-time clinical analysis
Fig. 2 – a) 2D photograph of burn on antecubital fossa (day 0); b) LDI image of burn (day 0); c) Thermal image of burn (day 0); d) 2D
photograph of burn (day 3); e) LDI image of burn (day 3); f) Thermal image of burn (day 3).
Please cite this article in press as: C. Wearn, et al., Prospective comparative evaluation study of Laser Doppler Imaging and thermal
imaging in the assessment of burn depth, Burns (2017), http://dx.doi.org/10.1016/j.burns.2017.08.004
JBUR 5341 No. of Pages 10
Table 5 – Comparative analysis of accuracy at predicting healing potential of ROIs to be >21 days. The total number used to
calculate Clinical Day 0 and 3 (photographic) is 4 times higher (208) than LDI, thermal and real-time assessments as the total
results for 4 assessors is used (i.e. 524=208).
Accuracy % Sensitivity % Specificity % PPV % NPV %
(n) (n; 95% CI) (n; 95% CI) (n; 95% CI) (n;95% CI)
LDI day 0 80.8 33.3 90.7 42.9 86.7
(42/52) (3/9; 2.5–64.1) (39/43; 82.0–99.4) (3/7; 6.2–79.5) (39/45; 76.7–96.6)
Thermal day 0 55.8 55.6 55.8 20.8 85.7
(29/52) (5/9; 23.1–88.0) (24/43; 41.0–70.7) (5/24; 4.6–37.1) (24/28; 72.6–98.7)
Clinical day 0 62.5 33.3 68.6 18.2 83.1
(photo, average) (130/208) (12/36; 19.1–51.1) (118/172; 56.8–71.6) (12/66; 9.1–27.3) (118/142; 74.5–88.1)
Real-time clinical day 0 88.5 33.3 100 100 87.8
(46/52) (3/9; 2.5–64.1) (43/43; 100.0–100.0) (3/3; 100.0–100.0) (43/49; 46.8–96.9)
LDI day 3 92.3 55.6 100 100 91.5
(48/52) (5/9; 23.1–88.0) (43/43; 100.0–100.0) (5/5; 100.0–100.0) (43/47; 83.5–99.4)
Thermal day 3 71.2 44.4 76.7 28.6 86.8
(37/52) (4/9; 12.0–76.9) (33/43; 64.1–89.4) (4/14; 4.9–52.2) (33/38; 76.1–97.6)
Clinical day 3 71.6 50.0 76.2 30.5 87.9
(photo, average) (149/208) (18/36; 33.2–66.8) (131/172; 69.0–82.2) (18/59; 19.5–44.0) (131/149; 81.3–92.5)
Please cite this article in press as: C. Wearn, et al., Prospective comparative evaluation study of Laser Doppler Imaging and thermal
imaging in the assessment of burn depth, Burns (2017), http://dx.doi.org/10.1016/j.burns.2017.08.004
JBUR 5341 No. of Pages 10
Fig. 3 – Relationship between mean flux [PU] and mean DT [ C] on day 0 and day 3.
Table 7 – P-values of cross-comparisons of accuracy values between day 0 clinical assessors (photographic) and day 0 LDI,
thermal imaging, real-time clinical assessment, and day 3 clinical assessments (photographic). Gray shaded cells denote
significance. P-values are from McNemar’s test.
Day 0 LDI Thermal Clinical (day 3) Clinical (real-time)
(accuracy%) (80.8%) (53.9%) (various) (88.46%)
Clinical assessor 1 <0.01 0.72 67.3%; 0.04 <0.01
(50.0%)
Clinical assessor 2 0.011 1.00 65.4%; 0.21 <0.01
(53.9%)
Clinical assessor 3 0.58 <0.01 80.8%; 0.58 0.02
(75.0%)
Clinical assessor 4 0.30 0.15 73.8%; 1.00 0.03
(71.5%)
Please cite this article in press as: C. Wearn, et al., Prospective comparative evaluation study of Laser Doppler Imaging and thermal
imaging in the assessment of burn depth, Burns (2017), http://dx.doi.org/10.1016/j.burns.2017.08.004
JBUR 5341 No. of Pages 10
Table 8 – P-values of cross comparisons of accuracy values comfortable Some patients however felt that the LDI equip-
between day 3 clinical and day 3 LDI and thermal imaging. ment was large and intimidating. A few patients (n=3)
Gray shaded cells denote significance. P-values are from appreciated being able to visualise in colours the superficial
McNemar’s test.
and deep areas of their wounds with both the LDI and thermal
Day 3 LDI Thermal imaging.
(accuracy %) (92.3%) (71.2%)
Clinical assessor 1 <0.01 0.31
(67.3%) 4. Discussion
Clinical assessor 2 <0.01 0.66
(65.4%) Clinical assessment has been shown in the literature to be less
Clinical assessor 3 0.11 0.33 than optimal and accurate in only 60-80% of cases especially in
(80.8%)
burns of intermediate or mixed depth and this can lead to
Clinical assessor 4 0.04 1.00
(73.1%)
unnecessary excision with worsened outcomes and aesthetic
results. Laser Doppler and thermal imaging have emerged as
adjuncts to help increase the accuracy of clinical burn depth
assessment and are the two most commonly used objective
Compared to day 0 LDI outcomes, there were no statistically methods to estimate the depth of burn via the indirect
significant differences in accuracy, sensitivity, specificity, and measurement of the cutaneous blood flow and as a prognostic
NPV. factor to predict healing time [21,22].
Real-time assessment however was found to have signifi- Our study has shown that LDI has a significantly higher
cantly higher accuracy (88.5% vs 55.8%, p<0.01), specificity accuracy on both day 0 and day 3 compared to thermal imaging
(100% versus 55.8%, p<0.01) and PPV (100% versus 20.8%, and photographic clinical assessment. This is mainly due to
p<0.05) compared to day 0 thermal imaging. Thermal imaging the significantly lower specificity (due to a high false positive
(D0) had a slightly higher sensitivity compared to real-time rate) of thermal imaging compared to LDI, leading to a
assessment but this did not reach statistical significance significantly better PPV for LDI versus thermal imaging (on
(55.6% versus 33.3%, p=0.68). day 3). There was no significant difference in NPV between all
Visual clues that clinicians felt were helpful to determine 3 modalities. A limitation of our study however is the wide
burn depth include the colour of the burn, presence of confidence intervals for sensitivity due to the relatively small
blanching and fixed red staining. Other factors deemed number of burn wounds that took longer than 21days to heal
important were the clinical history, anatomical area, age of (n=9). The small number of full thickness burns remaining was
patient, and type of dressings used. Interestingly, despite the due to our standard of care in which most deep dermal or full
better primary outcomes for photographic clinical assessment thickness wounds would be excised during the first few days of
on day 3, half of the clinicians felt that assessment of burn presentation unless they were indeterminate or too small in
depth was easier on day 0, with only 1 clinician saying it was size. Other studies have overcome this limitation by histologi-
easier on day 3 and one reporting that both days were the cally analysing excised burn tissue to determine burn depth
same. The reason given for this was that the visualization of [23]. This method however was not suitable for our study as we
burn wounds on day 3 were more likely to be hindered by defined ROI’s based on time of healing.
discolouration (e.g. by silver containing dressings or topicals,) Photographic clinical assessment of burn wounds in this
or exudates/crusts. study was performed via the analysis of 2D photographs. This
limits the depth indication clues available to the clinician to
3.3. Patient satisfaction questionnaire solely visual appearance and thus is only partly comparable to
real-time assessment [24].
Feedback was available from 11 of the 16 patients in the study. In fact, with the data that was available on real time clinical
The majority (64%, n=7/11) preferred the thermal camera as it assessment on day 0 from reviewing all patients records, there
was quicker compared to the LDI with the rest having no strong is an indication that real-time assessment on day 0 is not only
preference and stated both methods to be quick and superior to 2D photo assessment but thermal imaging day
Fig. 4 – Photographic assessment: Marginal distribution of burn depth assessments across the 4 clinicians on day 0 and day 3.
The graphs show the percentage of images that have been rated as deep or superficial by each clinician.
Please cite this article in press as: C. Wearn, et al., Prospective comparative evaluation study of Laser Doppler Imaging and thermal
imaging in the assessment of burn depth, Burns (2017), http://dx.doi.org/10.1016/j.burns.2017.08.004
JBUR 5341 No. of Pages 10
0 assessments as well. However it has to be noted that the real- opposite and made the whole wound wet instead [31],) and
time assessment in our study had some limitations: the wound covering the burn wounds with cling film before measurement
was assessed as a whole rather than for Region of Interest, data as several studies have suggested covering with a non-
were available only on admission (day 0) and were performed permeable membrane to prevent a falsely low temperature
by different consultants. secondary to evaporative heat loss [14,15,29]. However in our
Despite other studies that have compared LDI and thermal study, the images that we obtained with the cling film were
imaging showing that the former has a significantly better inferior to those without (e.g. poorer contrast between
accuracy [25], thermal imaging still remains a much re- different thermal zones) and contained artefacts due to
searched imaging modality in burns with several papers creases in the film rendering the images unsuitable for
published on the topic in the last few years. The main reasons thermal measurement and were thus not included in the
for this are the relatively lower cost, faster imaging time and final analysis. Sites which are being chosen as the controls
significantly better mobility of the thermal imaging devices. have to be selected carefully as well as temperatures have been
This is especially true with the release of newer smaller shown to vary in different areas of the body [32].
thermal cameras including models which can be attached to a Several authors have tried different techniques to stan-
mobile phone (FLIR One). Unlike the laser Doppler which dardize thermal imaging in hopes of improving its accuracy.
requires a relatively lengthy time to scan the region of interest Renkielska et al. [33,34] and Prindeze et al. [35] utilized active
(which increases with the size of the burn,), the thermal dynamic thermal imaging (ADT, cold excitation) to improve
camera offers a quicker, more portable and simpler alterna- the accuracy of thermal imaging. However utilizing the
tive. The instantaneous scan that thermal imaging produces complex protocol required for these methods negates the
allows burns to be assessed objectively quickly which is very most significant advantage of thermal imaging over LDI which
useful in children [26]. The patients in our study also showed a is speed of image acquisition (average time 3.6 versus 7.9min).
preference of the thermal camera due to it being faster and less This includes equipment set-up time, and the actual time for
intimidating compared to the LDI. One study has also shown image acquisition for the thermal camera is only a few seconds
that thermal imaging can be used to identify and quantify burn as it is “point and shoot”. Additionally, it is of note that
conversion utilising a modification of the technique [27]. guidelines for thermal imaging in other medical specialties
As thermal imaging utilises the infra-red (heat) signals recommend that the patient be allowed time (15–20min) to
emanating from the subject in comparison to the laser Doppler equilibrate with the temperature of the room before imaging is
which has employs its own stronger light source, thermal obtained [36,37]. Time is also required for the camera itself to
imaging will invariably be more susceptible to subject and equilibrate to the room temperature, although no specific
environmental changes and hence less accurate. Thus various times have been published by FLIR as it is dependent on both
aspects and steps in thermal imaging have to be standardized the temperature at which the camera is stored at and the room
to help make it more reproducible and accurate. in which it is used (direct correspondence with company,).
One of these includes standardizing the time of imaging to Cameras usually will have an indicator to show when
day 0 and 3 which has not always been done in other studies. equilibrium between the device and room temperature has
We have shown that LDI outperformed thermal imaging for been reached.
the primary outcome of diagnostic accuracy at predicting The main advantage that thermal imaging has in terms of
healing >21days on both day 0 and day 3. Furthermore, speed is being challenged with new innovations in other
thermal imaging was not found to be significantly better than technologies. Newer, faster models of LDI scanners have now
clinical judgement (both photographic and real-time) in terms been introduced onto the market e.g. the Laser Doppler Line
of accuracy for both day 0 and 3 which is in contrast to other Scanner (LDLS) which only takes 4s to scan an area of 300cm2
studies [28]. The increase in accuracy of burn depth assess- with comparable accuracy to traditional LDI imagers (94.2%
ment in all 3 modalities on day 3 compared to day 0 agrees with versus 94.4%) [38] as well as Laser Speckle Contrast Imaging
the reported literature. Hoeksema et al. reported that day which is also able to obtain images within seconds [39] but is
3 accuracies of both LDI and clinical assessments were higher however susceptible to motion artefacts (especially periodic
on day 3 compared to day 0 (97% versus 54%, and 40.6% versus movements e.g. breathing) which can be partially overcome by
61.5% respectively,). Liddington et al. also came to a similar taking a series of scan and choosing images with the lowest
conclusion which found that thermography of burns, to assess perfusion values [40]. Other technologies include devices
depth, should be performed within 3days following the injury which utilise spectrometry analysis [41,42] such as the
[29]. Miccio et al, in an animal study, showed that the Scanoskin [25] which is also “point and shoot” as well as
temperature half area (summation of temperatures across extremely mobile. Other promising technologies include
the burn wound) on day 2 had a stronger correlation with scar ultrasonography [43,44] especially in combination with real-
depth after healing compared to the measurements on day 1 time color flow imaging of the microcirculation [45] and laser-
[30]. Time points beyond 7days showed poor correlation with induced indocyanine green fluorescence [46].
scar depth.
Our experience is that the low accuracy of the thermal
camera is due to external environmental influences that were 5. Conclusions
not controlled adequately (e.g. wound exposure time, evapo-
ration, humidity etc.), which rendered the camera less Further work and innovation in the thermal imaging field
accurate than LDI imaging. In our study, we ensured wounds needs to be done in order to standardize the technique and
were dry (although interestingly one paper performed the improve the accuracy of the technology and preserve its place
Please cite this article in press as: C. Wearn, et al., Prospective comparative evaluation study of Laser Doppler Imaging and thermal
imaging in the assessment of burn depth, Burns (2017), http://dx.doi.org/10.1016/j.burns.2017.08.004
JBUR 5341 No. of Pages 10
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Conflict of interest
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