The Effect of Arista on Post-Operative Bleeding and Wound Drainage Following Mastectomy

Not Applicable

Completed

• Conditions: Seroma
• Interventions: Device: Microporous Polysaccharide Hemospheres (MPH)

• Registration Number: NCT03647930
• Lead Sponsor: Memorial Health University Medical Center

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.

Study Timeline

• Study Start: 2012-05-15
• Primary Completion: 2015-03-06
• Study Completion: 2015-03-06
• Status Verified: 2018-08
• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-23
• Last Update Submitted: 2018-08-23
• Study First Posted: 2018-08-27
• Last Update Posted: 2018-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Microporous Polysaccharide Hemospheres (MPH)	Application of Microporous Polysaccharide Hemospheres (MPH)

Primary Outcome Measures

Name	Time	Method
Total Drain Days	23 Days	Time to Drain Removal
Total Drain Output	23 Days	Total Drain Output in mL

Trial Locations

Locations (1)

Memorial Health University Medical Center; 🇺🇸 Savannah, Georgia, United States