LAUSR

BACKGROUND Mechanical stretching of the skin, in terms of tissue expansion, could generate additional skin, but it is limited by the intrinsic growth capacity. Here, we conducted on autologous concentrated growth factor (CGF) to promote skin regeneration by increasing skin thickness and area during tissue expansion. METHODS A single-center, randomized controlled trial (registered with ClinicalTrials.gov [NCT03406143]) was conducted from 2016 to 2019. Participants undergoing skin expansion received either CGF or saline via intradermal injection on the expanded skin (0.02 ml/cm 2), for a total of three treatments at 4-week intervals. The primary endpoint was the expanded skin thickness at 12 weeks, which was measured by ultrasound. The secondary endpoints included the skin thickness at 4 and 8 weeks and the surface area, expansion index (EI), and skin texture score of the expanded skin at 12 weeks. Safety assessments, such as infection symptoms and nodule formation, were assessed at 24 weeks. RESULTS In total, 26 patients were enrolled and assigned to the CGF group or the control group. Compared with the control group, the CGF group had significantly increased skin thickness at 8 (control: 1.1 ± 0.1 mm, CGF: 1.4 ± 0.1 mm; -0.6 mm to 0.0 mm, p = 0.047) and 12 weeks (control: 1.0 ± 0.1 mm, CGF: 1.3 ± 0.1 mm; -0.6 mm to 0.0 mm, p = 0.047). Compared with the baseline thickness (control: 1.6 ± 0.1 mm, CGF: 1.5 ± 0.1 mm; -0.3 mm to 0.5 mm, p=0.987), skin thickness was sustained in the CGF group at 8 weeks posttreatment (-0.1 mm to 0.3 mm, p = 0.711) but decreased in the control group (0.3 mm to 0.7 mm, p＜0.001). At 12 weeks, the CGF group showed greater increases in surface area (control: 77.7 ± 18.5 cm 2, CGF: 135.0 ± 15.7 cm 2; 7.2 cm 2 to 107.4 cm 2, p = 0.027) and EI (control: 0.9 ± 0.1, CGF: 1.4 ± 0.2; 0.0 to 0.8, p=0.030) than the control group. Additionally, CGF-treated skin showed an improvement in texture (CGF: grade 3: 2 [15.8%], grade 2: 4 [30.7%]; control: grade 3: 0 [0.0%], grade 2: 3 [23.0%]). No severe adverse events occurred. CONCLUSION CGF treatment increases skin thickness and area during tissue expansion, as represents a safe and effective strategy for managing skin expansion. EVIDENCE RATING Therapeutic Studies, Level II.