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

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.

Study Overview

• Status: Completed
• Conditions: Seroma
• Intervention / Treatment: Device: Microporous Polysaccharide Hemospheres (MPH)

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Savannah, Georgia, United States, 31404
      • Memorial Health University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Application of Microporous Polysaccharide Hemospheres (MPH)	Device: Microporous Polysaccharide Hemospheres (MPH); Microporous Polysaccharide Hemospheres (MPH)
No Intervention: Control; No MPH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Drain Days	Time to Drain Removal	23 Days
Total Drain Output	Total Drain Output in mL	23 Days

Collaborators and Investigators

• Sponsor: Memorial Health University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2012
• Primary Completion (Actual): March 6, 2015
• Study Completion (Actual): March 6, 2015

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): August 27, 2018
• Last Update Submitted That Met QC Criteria: August 23, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Hemorrhage; Postoperative Hemorrhage
• Other Study ID Numbers: MHUMC 2012.05.05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No