1.
The effects of poloxamer and sodium alginate mixture (Guardix-SG®) on range of motion after axillary lymph node dissection: A single-center, prospective, randomized, double-blind pilot study.
Lee, SB, Gwark, SC, Kang, CM, Sohn, G, Kim, J, Chung, IY, Lee, JW, Kim, HJ, Ko, BS, Ahn, SH, et al
PloS one. 2020;(9):e0238284
Abstract
PURPOSE Restricted shoulder mobility is a major upper extremity dysfunction associated with lower quality of life and disability after breast cancer surgery. We hypothesized that a poloxamer and sodium alginate mixture (Guardix-SG®) applied after axillary lymph node dissection (ALND) would significantly improve shoulder range of motion (ROM) in patients with breast cancer. METHODS We conducted a double-blind, randomized, prospective study to evaluate the clinical efficacy and safety of Guardix-SG® for the prevention of upper extremity dysfunction after ALND. The primary outcome measure was shoulder ROM at baseline (T0) and 3 (T1), 6 (T2), and 12 months (T3) after surgery. Secondary outcome measures were the Disabilities of the Arm, Shoulder, and Hand score(DASH), pain associated with movement, which was assessed using a numeric rating scale, and lymphedema assessed using body composition analyzer. RESULTS A total of 83 women with breast cancer were randomly assigned to either the Guardix-SG® group or the control group. In the Guardix-SG® group (n = 37), Guardix-SG® was applied to the axillary region after ALND. In the control group (n = 46), ALND was performed without using Guardix-SG®. Comparing ROM for shoulder flexion before surgery (178.2°) and 12 months after surgery (172.3°), that was restored 12 months after surgery in the Guardix-SG® group, and there was no statistically significant difference between that at before surgery and 12 months after surgery (p = 0.182). No adverse effect was observed in either group. CONCLUSIONS The results of this study have shown that Guardix-SG® help improve shoulder ROM without causing adverse effects in patients who underwent breast cancer surgery. However, there was no statistically significant difference from the control group. A further large-scale study is needed to obtain a more conclusive conclusion. TRIAL REGISTRATION CRISKCT0003386; https://cris.nih.go.kr (20181207).
2.
An autologous protein gel for soft tissue augmentation: in vitro characterization and clinical evaluation.
Fedyakova, E, Pino, A, Kogan, L, Eganova, C, Troya, M, Anitua, E
Journal of cosmetic dermatology. 2019;(3):762-772
Abstract
BACKGROUND The aging process affects all organs of the body, but the skin is the most visible indicator with a great psychosocial impact. As a consequence, many skin anti-aging strategies have been developed to minimize, postpone, and even reverse the aging process. Growth factors have been widely studied in skin wound healing as these polypeptides play an essential role in the complex process of tissue regeneration. Recently, a novel 3D injectable gel based on the autologous technology platelet rich in growth factor has been described. OBJECTIVES In this study, a comparison between hyaluronic acid (HA, the gold standard for skin rejuvenation), and this novel autologous formulation has been conducted. METHODS Rheological and mechanical properties were determined. The in vitro biological capacity of both treatments on human dermal fibroblasts proliferation, migration, chemotaxis, and extracellular matrix synthesis was also assessed. Additionally, a clinical evaluation of the autologous platelet gel treatment was performed by macrophotographs, ultrasound analyses, and clinical and patient surveys. RESULTS The autologous gel outperformed the general biomechanical properties of HA and kept an optimal viscoelastic gel-like behavior for soft tissue augmentation. Both formulations stimulated cell chemotaxis, migration, and type I collagen synthesis. The autologous gel induced a statistically higher cell proliferation. After the autologous formulation treatment, a soft tissue augmentation effect was also noticed along with an overall skin quality improvement in terms of hydration, elasticity, wrinkle reduction, and general satisfaction scores. CONCLUSIONS This novel injectable formulation has desirable mechanical and bioactive properties for 3D tissue regeneration and might offer a safe and effective treatment for depressed areas of the skin.