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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03647930
Other study ID # MHUMC 2012.05.05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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