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

• DOI: 10.1371/journal.pone.0238284
• Publication Date: 2020-09-23T17:30:46Z
• Authors: Sae Byul Lee; Sung-chan Gwark; Cheol Min Kang; Guiyun Sohn; Jisun Kim; Il Yong Chung; Jong Won Lee; Hee Jeong Kim; Beom Seok Ko; Sei-Hyun Ahn; Won Kim; Junghwa Do; Jae Yong Jeon; Jinsung Kim; Eunhae Um; Tae in Yoon; Sung-ui Jung; Minkyu Han; Byung Ho Son
• Keywords: Shoulder; Science; Breast Neoplasms; Pilot Projects; Poloxamer; 03 medical and health sciences; 0302 clinical medicine; Double-Blind Method; Humans; Prospective Studies; Hyaluronic Acid; Range of Motion, Articular; Mastectomy; Q; R; Middle Aged; Prognosis; 3. Good health; Drug Combinations; Carboxymethylcellulose Sodium; Case-Control Studies; Lymphatic Metastasis; Axilla; Medicine; Lymph Node Excision; Female; Research Article; Follow-Up Studies

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 poloxamer sodium alginate mixture (Guardix-SG®) applied axillary lymph node dissection (ALND) would significantly improve range motion (ROM) in patients cancer. Methods conducted double-blind, randomized, prospective study to evaluate the clinical efficacy safety Guardix-SG® for prevention ALND. The primary outcome measure was ROM at baseline (T0) 3 (T1), 6 (T2), 12 months (T3) Secondary measures were Disabilities Arm, Shoulder, Hand score(DASH), pain movement, which assessed using numeric rating scale, lymphedema body composition analyzer. Results A total 83 women randomly assigned either group or control group. In (n = 37), region 46), ALND performed without Guardix-SG®. Comparing flexion before surgery (178.2°) (172.3°), restored group, there no statistically significant difference between (p 0.182). No adverse effect observed Conclusions results this have shown help causing effects who underwent However, from further large-scale needed obtain more conclusive conclusion. Trial registration CRISKCT0003386; https://cris.nih.go.kr (20181207)