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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Draining Wound Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early-drain removal

Procedure

Drain removal at hospital discharge

Primary outcomes

Quality of Life

Time frame: 3 weeks

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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study 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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Apr 7, 2017
Registry last updated: Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed