Clinical trial NCT03647930: The Effect of Arista on Post-Operative Bleeding and Wound Drainage Following Mastectomy
Official title: The Effect of Arista on Post-Operative Bleeding and Wound Drainage Following Mastectomy: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seroma
Lead sponsor: Memorial Health University Medical Center
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Undergoing simple mastectomy with or without sentinel lymph nodes biopsy OR modified radical mastectomy for the treatment of breast cancer

Exclusion Criteria:

* Undergoing partial mastectomy
* Sentinel lymph node biopsy requiring conversion to axillary lymph node dissection
* Immediate reconstructive surgery
* Systemic anticoagulation
* Choosing not to participate in the study

Primary outcomes:
measure: Total Drain Days
timeFrame: 23 Days
measure: Total Drain Output
timeFrame: 23 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
Study officials:
References:
citation: Suarez-Kelly LP, Pasley WH, Clayton EJ, Povoski SP, Carson WE, Rudolph R. Effect of topical microporous polysaccharide hemospheres on the duration and amount of fluid drainage following mastectomy: a prospective randomized clinical trial. BMC Cancer. 2019 Jan 23;19(1):99. doi: 10.1186/s12885-019-5293-1.