NCT03104153

Brief Summary

To compare early drain removal versus output-based drain removal, assessing the following end-points: Clinical : risk of seroma and infection, woundhealing, duration of wound care and drain output versus volume of seroma. Quality of life : drain-induced pain, discomfort due to seroma or drain, sleep disturbance and implications on daily activities. Cost-effectiveness

Trial Health

100
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

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

September 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
Last Updated

November 29, 2023

Status Verified

March 1, 2017

Enrollment Period

8 months

First QC Date

March 27, 2017

Last Update Submit

November 28, 2023

Conditions

Draining WoundBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    Improve the quality of life, wich will be measured by a questionnaire with some specific questions.

    3 weeks

Study Arms (2)

Output-based

NO INTERVENTION

Early-removal

ACTIVE COMPARATOR
Procedure: Early-drain removal

Interventions

Early-drain removalPROCEDURE

Drain removal at hospital discharge

Early-removal

Eligibility Criteria

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

You may qualify if:

  • Patient scheduled for breast cancer surgery with placement of suction drainage
  • Female or male
  • Age \> 18 years

You may not qualify if:

  • Patients scheduled for breast cancer surgery without placement of suction drains
  • No informed consent: Patient refuses participation OR is not able to give a written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2017

First Posted

April 7, 2017

Study Start

September 1, 2015

Primary Completion

April 30, 2016

Study Completion

June 30, 2016

Last Updated

November 29, 2023

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share