Seroma Clinical Trial
Official title:
The Effect of Arista on Post-Operative Bleeding and Wound Drainage Following Mastectomy: A Prospective Randomized Trial
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.
Seroma 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.
Prospective 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.
Fifty 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.
Unlike 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.
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