Clinical effects of high-intensity laser therapy on patients with chronic refractory wounds: a randomised controlled trial.

Objective To investigate the effectiveness of high-intensity laser therapy (HILT) on chronic refractory wounds. Design Randomised controlled trial. Setting The outpatient wound care department of the Affiliated Jiangsu Shengze Hospital of Nanjing Medical University from August 2019 to June 2020. Participants Sixty patients were enrolled in this study and were randomised into control (n=30) and treatment (n=30) groups. Interventions and outcome measures The control group was treated only with conventional wound dressing, whereas the treatment group received irradiation with HILT in addition to standard wound care, such as debridement, wound irrigation with normal saline solution and application of dressing and sterile gauze. Patient scores on the Bates-Jensen Wound Assessment Tool (BWAT) and Pressure Ulcer Scale for Healing (PUSH) were evaluated before and after 1, 2 and 3 weeks of treatment. Results One patient was excluded from the control group, and a total of 59 subjects completed the trial. The BWAT scores significantly decreased in the treatment group compared with the control group at the end of 3-week treatment (difference=−3.6; 95% CI −6.3 to–0.8; p<0.01). Similarly, patients in treatment group showed a significant reduction of PUSH scores compared with the control group (difference=−5.3; 95% CI −8.1 to –2.6; p<0.01). Conclusions The therapeutic effects of HILT on chronic refractory wounds are significant and far more superior to those of conventional wound dressing. Trial registration number Chinese Clinical Trial Registry; ChiCTR1900023157. URL: http://www.chictr.org.cn/showproj.aspx?proj=38866