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

Seroma Clinical Trial

Official title:

The Effect of Arista on Post-Operative Bleeding and Wound Drainage Following Mastectomy: A Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03647930
• Other study ID #: MHUMC 2012.05.05
• Status: Completed
• Phase: N/A
• Start date: May 15, 2012
• Est. completion date: March 6, 2015

Study information

• Verified date: August 2018
• Source: Memorial Health University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 6, 2015
• Est. primary completion date: March 6, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Hemorrhage
• Seroma

Intervention

Device:
• Microporous Polysaccharide Hemospheres (MPH)
Microporous Polysaccharide Hemospheres (MPH)

Locations

Country	Name	City	State
United States	Memorial Health University Medical Center	Savannah	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Health University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Drain Days	Time to Drain Removal	23 Days
Primary	Total Drain Output	Total Drain Output in mL	23 Days