Effect of Poloxamer-Based Thermo-Sensitive Sol-Gel Agent on Upper Limb Dysfunction after Axillary Lymph Node Dissection: A Double-Blind Randomized Clinical Trial

Abstract

Purpose Restricted shoulder motion is a major morbidity associated with a lower quality of life and disability after axillary lymph node dissection (ALND) in patients with breast cancer. This study sought to evaluate the antiadhesive effect of a poloxamer-based thermosensitive sol-gel (PTAS) agent after ALND. Methods We designed a double-blind, multicenter randomized controlled study to evaluate the clinical efficacy and safety of PTAS in reducing upper-limb dysfunction after ALND. The primary outcome was the change in the range of motion (ROM) of the shoulder before surgery and 4 weeks after ALND (early postoperative period). Secondary outcomes were shoulder ROM at six months, axillary web syndrome, and lymphedema (late postoperative period). Results A total of 170 patients with planned ALND were randomly assigned to one of 2 groups (poloxamer and control) and 15 patients were excluded. In the poloxamer group (n = 76), PTAS was applied to the surface of the operative field after ALND. ALND was performed without the use of poloxamer in the control group (n = 79). Relative to the control group, the poloxamer group had significantly lower early postoperative restrictions in total shoulder ROM at four weeks (−30.04 ± 27.76 vs. −42.59 ± 36.79; p = 0.0236). In particular, the poloxamer group showed greater reductions in horizontal abduction at four weeks (−3.92 ± 9.80 vs. −10.25 ± 15.42; p = 0.0050). The ROM of the shoulder at 24 weeks, axillary web syndrome, and lymphedema were not significantly different between the two groups. No adverse effects were observed in either group. Conclusion We suggest that poloxamer might improve the early postoperative shoulder ROM in patients with breast cancer who have undergone ALND. Trial Registration ClinicalTrials.gov Identifier: NCT02967146

Effects of an anti-adhesive agent on capsule formation in implant-based breast reconstruction: A randomized controlled trial

“…Mediclore has been previously proven to be safe and effective in preventing the formation of adhesions after various operations including total knee arthroplasty, 6 dacryocystorhinostomy, 7 parotidectomy, 8 transurethral resection of the prostate, 9 gynecologic surgery, 10 rotator cuff repair, 11 and axillary lymph node dissection. 12 Previous animal studies have reported that AAAs inhibit periprosthetic capsule formation by reducing inflammation and fibrosis. [13][14][15] However, no study has explored the therapeutic effects of AAA and its underlying mechanism of reducing capsule formation in a clinical setting.…”

“…Mediclore has been previously proven to be safe and effective in preventing the formation of adhesions after various operations including total knee arthroplasty, 6 dacryocystorhinostomy, 7 parotidectomy, 8 transurethral resection of the prostate, 9 gynecologic surgery, 10 rotator cuff repair, 11 and axillary lymph node dissection. 12…”