Advice
Clinical and technical evidence
Clinical and technical evidence
A literature search was done for this briefing in accordance with NICE's interim process and methods statement for medtech innovation briefings. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.
Published evidence
Five studies are summarised in this briefing, including a total of 557 people with burns. Two studies are randomised controlled trials that compared clinical outcomes (such as the length of stay) for moorLDLS‑BI with clinical assessment (Hop et al. 2016; Venclauskiene et al. 2014). Both are non‑UK studies.
The other 3 are cross‑sectional studies designed to compare the accuracy of predicting wound healing using moorLDLS‑BI with clinical evaluation (Hoeksema et al. 2014; Holland et al. 2014 and Hoeksema et al. 2011). People from 2 UK burn centres were included in Hoeksema et al. (2014).
The clinical evidence and its strengths and limitations is summarised in the overall assessment of the evidence.
Overall assessment of the evidence
The current evidence suggests that the moorLDLS‑BI system is safe and that using the device in burn assessment would be feasible.
Trials suggested that the use of moorLDLS‑BI was associated with shorter wound‑healing time compared with clinical assessment. The difference between the 2 groups was significant in the small trial (n=57, Venclauskiene et al. 2014) but not in the large trial (n=202, Hop et al. 2016). So, more trials are needed to show the clinical benefits of the technology. A group of people from a Belgian clinic overlapped in the 2 Hoeksema et al. studies.
Hop et al. (2016, an abstract)
Study size, design and location
A multicentre randomised controlled trial in Belgium of 202 people with burns of indeterminate depth.
Intervention and comparator
People were randomised into 2 groups:
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moorLDLS‑BI combined with clinical assessment
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clinical assessment only (standard care).
Key outcomes
The study reported that mean time to wound healing was 14.3 days (95% confidence interval [CI] 12.8 to 15.9) in the moorLDLS‑BI group and 15.5 days (95% CI 13.9 to 17.2) in the standard care group (p=0.258). In the moorLDLS‑BI group there was a statistically significant increase in the number of immediate treatment decisions (either surgical or non‑surgical) compared with the standard care group (p<0.001), where more decisions to postpone treatment were made. In a subgroup analysis, people who needed surgery showed a significant earlier decision for surgery and a shorter wound‑healing time in the moorLDLS‑BI group than in the standard care group.
Hoeksema et al. (2014)
Intervention and comparator
People were scanned using moorLDLS‑BI to assess their burns and subsequent healing. The assessment used clinical photographs as the gold standard for proof of healing and non‑healing at 14 days and 21 days after the burn. The photographs were assessed by experienced healthcare professionals. The healing potential prediction from moorLDI2‑BI was used as a non‑standard reference when clinical photographs were not available.
Key outcomes
A total of 596 wounds from 204 people were available for analysis from the clinical investigation. There were 77 wounds used for scalar definition and 321 used for healing potential accuracy assessment for LDI and moorLDLS‑BI, comparing them with actual healing based on clinical photos. There were 198 wounds categorised separately because they were skin grafted or there were no clinical photos or clinical information available. The accuracy assessment using moorLDLS‑BI of these wounds were compared with results from moorLDI2‑BI scanner.
For observed healing, the accuracy of the moorLDLS‑BI was 94.2% compared with clinical records in 321 wounds with a sensitivity of 91.9% and specificity of 96.0%. The accuracy of the moorLDI2‑BI was 93.5%, the sensitivity 90.3% and the specificity 95.2%.
The agreement between moorLDLS‑BI and moorLDI2‑BI was 94.9% for healing potential within 14 days, 93.6% for healing potential between 14 days and 21 days and 98.8% for healing potential after more than 21 days.
Strengths and limitations
This study had predefined inclusion and exclusion criteria. A potential selection bias was identified because people who were unable to remain still enough for an adequate LDI to be taken, were excluded. A selection of wounds (n=198) was not able to be assessed because they were skin grafted or there were no clinical photos or precise clinical information.
Holland et al. (2014)
Intervention and comparator
Between February 2010 and March 2011 children who were referred to the burn centre with an acute burn had their burn wounds scanned concurrently using moorLDLS‑BI and moorLDI2‑BI scanners. All scans were done between 42 hours and 5 days of the burn.
Wound healing or the need for surgical intervention were assessed by the treating clinician.
Key outcomes
Of the 50 children enrolled, 1 was excluded from subsequent analysis because follow‑up clinical images were not available. Of the remaining 49 children, 90 scans were done on 59 burn wounds. Most of the burns were scalds (n=30, 61%), followed by contact (n=11, 23%), flame (n=5, 10%) and friction (n=3, 6%). Of the 59 burn wounds, 48 healed within 14 days, 6 healed within 14 to 21 days and 5 did not heal within 21 days.
Overall accuracy of the scanners was 95% (moorLDLS‑BI) and 94.5% (moorLDI2‑BI). The sensitivity of moorLDLS‑BI for predicting healing within 14 days was 98% compared with moorLDI‑BI. The sensitivity of moorLDLS‑BI for predicting healing between 14 and 21 days and after 21 days was 70% and 92%, respectively. The specificity of moorLDLS‑BI for predicting healing within 14 days, between 14 and 21 days and after 21 days was 79%, 95% and 97%, respectively.
Venclauskiene et al. (2014)
Intervention and comparator
People with burn wounds were randomised 72 hours after the burn into 2 groups: clinical burn depth examination (CDE) or LDI using a moorLDLS‑BI.
The depth of the injured tissue was assessed during CDE and LDI scan. The depth of injured tissue was divided into superficial (1 and 2A burn degree) and deep burns (2B and 3 burn degree). The burn wound biopsy was done by a surgeon in the same burn location to detect the correlation of findings of CDE and LDI scan.
Key outcomes
During a 2‑year study period, 32 people were assigned to the CDE group and 25 people to the LDI group using moorLDLS‑BI. moorLDLS‑BI scan correlated with biopsy in 22 out of 25 patients (88%), while CDE correlated with biopsy in 23 out of 32 patients (71.9%).
The mean length of stay in hospital was significantly higher in the CDE group (47 days, standard deviation [SD]=34.4) compared with the LDI group (25 days, SD=10.8; p=0.005). The mean cost of treating burns was significantly higher in the CDE group (€4,941.30, equivalent to £4,446.90) than in the LDI group (€2,562.80, equivalent to £2,306.52; p=0.001).
People in the CDE group with deep burns who had surgery had a significantly longer stay in hospital and had significantly more expensive treatment compared with people in the LDI scan group.
Strengths and limitations
This is a single‑centre study. The study author noted that biopsy is considered the most accurate way to diagnose the depth of burn wounds. The burn wound biopsy should be done within 48 to 72 hours after burns but biopsies in this clinical study were done 72 hours after burns. Time intervals between biopsy and clinical examination or laser doppler scan were not reported in the study.
Hoeksema et al. (2011)
Intervention and comparator
moorLDLS‑BI and LDI images were obtained at 2 to 5 days after burn. Photographs and records of healing were obtained at scan day (2 to 5 days after burn) and 14 days and 21 days after burn.