NCT03647930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2015

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

2.8 years

First QC Date

August 23, 2018

Last Update Submit

August 23, 2018

Conditions

Seroma

Outcome Measures

Primary Outcomes (2)

  • Total Drain Days

    Time to Drain Removal

    23 Days

  • Total Drain Output

    Total Drain Output in mL

    23 Days

Study Arms (2)

Intervention

EXPERIMENTAL

Application of Microporous Polysaccharide Hemospheres (MPH)

Device: Microporous Polysaccharide Hemospheres (MPH)

Control

NO INTERVENTION

No MPH

Interventions

Microporous Polysaccharide Hemospheres (MPH)DEVICE

Microporous Polysaccharide Hemospheres (MPH)

Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Related Publications (1)

  • 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.

    PMID: 30674296DERIVED

MeSH Terms

Conditions

Seroma

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Prospective randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 27, 2018

Study Start

May 15, 2012

Primary Completion

March 6, 2015

Study Completion

March 6, 2015

Last Updated

August 27, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)