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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03104153
Enrollment
106
Registered
2017-04-07
Start date
2015-09-30
Completion date
2016-06-30
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Draining Wound

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

Interventions

PROCEDUREEarly-drain removal

Drain removal at hospital discharge

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Life3 weeksImprove the quality of life, wich will be measured by a questionnaire with some specific questions.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026