search
Back to results

Effect of Early Removal of Wound Drains After Mastectomy or Lymph Node Dissection

Primary Purpose

Draining Wound, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Early-drain removal
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Draining Wound

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient scheduled for breast cancer surgery with placement of suction drainage
  • Female or male
  • Age > 18 years
  • All stages of disease (inclusion is independent of TNM-classification)

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Output-based

    Early-removal

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    March 27, 2017
    Last Updated
    March 31, 2017
    Sponsor
    Universitaire Ziekenhuizen KU Leuven
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03104153
    Brief Title
    Effect of Early Removal of Wound Drains After Mastectomy or Lymph Node Dissection
    Official Title
    Effect of Early Removal of Wound Drains After Mastectomy or Lymph Node Dissection on Clinical Outcome and Quality of Life in Breast Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2015 (Actual)
    Primary Completion Date
    April 30, 2016 (Actual)
    Study Completion Date
    June 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universitaire Ziekenhuizen KU Leuven

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Draining Wound, Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    106 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Output-based
    Arm Type
    No Intervention
    Arm Title
    Early-removal
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Early-drain removal
    Intervention Description
    Drain removal at hospital discharge
    Primary Outcome Measure Information:
    Title
    Quality of Life
    Description
    Improve the quality of life, wich will be measured by a questionnaire with some specific questions.
    Time Frame
    3 weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient scheduled for breast cancer surgery with placement of suction drainage Female or male Age > 18 years All stages of disease (inclusion is independent of TNM-classification) Exclusion Criteria: 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Early Removal of Wound Drains After Mastectomy or Lymph Node Dissection

    We'll reach out to this number within 24 hrs