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

Effect of Early Removal of Wound Drains After Mastectomy or Lymph Node Dissection on Clinical Outcome and Quality of Life in Breast Cancer Patients

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Draining Wound
• Intervention / Treatment: Procedure: Early-drain removal

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Output-based
Active Comparator: Early-removal	Procedure: Early-drain removal; Drain removal at hospital discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	Improve the quality of life, wich will be measured by a questionnaire with some specific questions.	3 weeks

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): April 30, 2016
• Study Completion (Actual): June 30, 2016

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Wounds and Injuries
• Other Study ID Numbers: S58129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No