Evaluation of local hemostatic effect of microporous polysaccharide hemospheres products in thyroid surgery: a prospective randomized controlled study

Abstract

Objective: Bleeding is a rare and dangerous complication of thyroid surgery. One of the hemostatic agents used during surgery are microporous polysaccharide hemospheres (MPH) which are local hemostatic agents acquired from purified potato starch. The aim of this study was to evaluate the efficiency of two MPH, produced with different biotechniques, in decreasing hemorrhages and drainage following thyroidectomy. Material and Methods: A statistical power analysis predicted that totally 20 patients per each group was needed within 95% confidential interval. Patients were randomized into 3 groups as control, Haemocer TM and Arista TM to be 20 patients in each group. Following bilateral total thyroidectomy, no additional procedures were performed in the first group, 5 g Haemocer was administered to the second group, 5 g Arista was administered to the third group into the operational field, and the operation was ended by placing a double-sided hemovac drain. At post-operative day one, drainage amount, calcium (Ca), phosphate (P) and parathyroid hormone (PTH) levels were noted. Results: No significant difference was noted between the groups for age, gender, removed tissue weight and malignant pathology rates. Also, no significant difference was noted between post-operative drainages and Ca, P, PTH levels of groups either. Hoarseness or hematoma were not observed in any patient. Conclusion: MPHs are not proven in effectiveness in decreasing post-operative hemorrhages, which might be a key to avoiding unnecessary expenses.

Effect of microporous polysaccharide hemospheres on anterolateral thigh free flap donor site complications

“…Despite promising animal studies 14,15 and a recent retrospective study of MPH use in ALT donor sites where the use of MPH was associated with lower rates of seroma formation and were associated with earlier drain removal, 19 we did not detect a significant difference in postoperative drain output, seroma development, or hematoma development with the use of MPH. This is consistent with other randomized controlled trials that found no significant improvement in postoperative surgical site drainage with MPH after mastectomy or total thyroidectomy 23,24 . On the other hand, in an unpublished retrospective cohort of more than 100 patients performed at our institution prior to initiating this trial, we found that MPH use was associated with decreased rates of ALT donor site seroma formation and earlier surgical drain removal.…”

“…This is consistent with other randomized controlled trials that found no significant improvement in postoperative surgical site drainage with MPH after mastectomy or total thyroidectomy. 23,24 On the other hand, in an unpublished retrospective cohort of more than 100 patients performed at our institution prior to initiating this trial, we found that MPH use was associated with decreased rates of ALT donor site seroma formation and earlier surgical drain removal. MPH has shown some benefit in certain surgical procedures such as improved hemostasis following brain tumor resection in a case series of 33 patients.…”

“…As previously mentioned, two randomized controlled trials have not found significant benefit in the use of MPH 23,24 . In fact, bandages with MPH applied to skin defects from Mohs surgery actually increased bleeding through the bandage and did not significantly affect bleeding after bandage removal 27 .…”

“…26 As previously mentioned, two randomized controlled trials have not found significant benefit in the use of MPH. 23,24 In fact, bandages with MPH applied to skin defects from Mohs surgery actually increased bleeding through the bandage and did not significantly affect bleeding after bandage removal. 27 MPH may similarly worsen bleeding after total knee arthroplasty 28 and in one animal study, it resulted in an increased risk of distal tip necrosis of local skin flaps.…”

FDG PET/CT Features of Polysaccharide-Based Hemostatic Agent

“…There are a limited number of studies investigating the effectiveness of polysaccharide-based HAs 5–7 . Therewithal, HAs can lead to some clinical complications such as inflammatory reactions or tumor-like mass lesions that have also been reported 8–10 .…”