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.
Highlights
Seroma formation is the most common complication after mastectomy and places patients at risk of associated morbidities
The purpose of this study was to evaluate the efficacy of topical Microporous polysaccharide hemospheres (MPH) used together with closed suction drainage, compared to suction drainage alone, in the reduction of drain output and time to drain removal following mastectomy for the treatment of breast cancer (BC)
One patient experienced a postoperative complication; wound infection and dehiscence. This patient was in the MPH group and had a body mass index (BMI) < 30
Summary
Seroma formation is the most common complication after mastectomy and places patients at risk of associated morbidities. 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. The most common complication following breast cancer (BC) surgery is seroma formation [1]. A seroma results from an accumulation of serous fluid in the dead space of the breast, under the skin flaps, or axilla following breast surgery. Several surgical techniques have been used to reduce seroma formation; use of ultrasonic scissors, physical closure of dead space, suction drainage, and placement of external compression dressings [3, 5]. No method has been described to consistently and reliably prevent seroma formation
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