Technology and indications
The LumiHeal™ KLOX system is composed by a lamp, the KLOX KT – L™ or KLOX KT – C™ (KLOX KT – L/C™), and a topical photo-converter gel, the KLOX LumiHeal™ gel. The technology is manufactured by KLOX Technologies Inc. and received the CE mark in 2015. The system is designed to promote healing of wounds while addressing bacterial contamination. Within the Region, three hospitals requested the technology with the intention to use it for the management of complex wounds.
Diffusion of the technology in Italy
During 2017, 12 units of the KLOX LumiHeal™ gel have been purchased by one single Region. A total of 96 units have been purchased in Emilia Romagna during the first semester 2018 with price ranging from EUR 70.76 to EUR 73.20.
Comparators
The current treatment of skin lesions counts several options. While advanced dressings represent, in many cases, the standard of care, several other approaches have been developed, such as cellular and tissue engineering, negative pressure, hyperbaric therapy, electrotherapy and ultrasound therapy. Level of evidence of these treatment alternatives is variable.
Preliminary evidence summary
Searches of secondary studies did not identify any relevant reference.
Searches of primary studies identified only one study on the LumiHeal™ KLOX system reporting preliminary results on 33 patients out of 100. The study is being performed in Italy and is multicentre and non-comparative in design. Other two case-series were presented on the manufacturer’s website but they were published in journals that were not indexed either in Pubmed or Embase.
Searches of ongoing studies identified further three relevant studies which were labelled as concluded but had no published results.
Conclusions
Even if promising, results are only preliminary and coming from low quality studies with small sample size.
See the full report in Italian here.
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