Effect of topical microporous polysaccharide hemospheres on the duration and amount of fluid drainage following mastectomy: a prospective randomized clinical trial

Abstract

BackgroundSeroma formation is the most common complication after mastectomy and places patients at risk of associated morbidities. Microporous polysaccharide hemospheres (MPH) consists of hydrophilic, plant based, polysaccharide particles and is currently used as an absorbable hemostatic agent. An animal model evaluating MPH and seroma formation after mastectomy with axillary lymph node dissection showed a significant decrease in seroma volume. Study aim was to evaluate topical MPH on the risk of post-mastectomy seroma formation as measured by total drain output and total drain days.MethodsProspective randomized single-blinded clinical trial of patients undergoing mastectomy for the treatment of breast cancer. MPH was applied to the surgical site in the study group and no application in the control group.ResultsFifty patients were enrolled; eight were excluded due to missing data. Forty-two patients were evaluated, control (n = 21) vs. MPH (n = 21). No difference was identified between the two groups regarding demographics, tumor stage, total drain days, total drain output, number of clinic visits, or complication rates. On a subset analysis, body mass index (BMI) greater than 30 was identified as an independent risk factor for high drain output. Post hoc analyses of MPH controlling for BMI also revealed no statistical difference.ConclusionsUnlike the data presented in an animal model, no difference was demonstrated in the duration and quantity of serosanguinous drainage related to the use of MPH in patients undergoing mastectomy for the treatment of breast cancer. BMI greater than 30 was identified as an independent risk factor for high drain output and this risk was not affected by MPH use. NCT03647930, retrospectively registered 08/2018.

Quilting suture is better than conventional suture with drain in preventing seroma formation at pectoral area after mastectomy

“…This study showed that quilting suture was associated with lower incidence of Grade 2 and 3 seroma compared with that of conventional suture within 1 month after mastectomy with SLN or ALND, especially for the late seroma in Grade 2 and 3. This study also showed that old age and high BMI were risk factors on postoperative seroma formation, consistent with previous results from similar studies [9,11,[21][22][23].…”

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.…”

“…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 .…”

Lymphocele or Seroma After Modified Radical Mastectomy for Breast Cancer: Systematic Review and Meta-analysis.

“…They are also a source of discomfort for patients. Many techniques have been developed to decrease the risk of seroma formation: wound drainage 3 , reduction of the dead space by ap xation 4 , use of various types of energy 5 , external compression dressings 6 , shoulder immobilization or physical activity 7 , as well as numerous drugs and glues [8][9][10][11] .…”