Effect of Early Removal of Wound Drains After Mastectomy or Lymph Node Dissection on Clinical Outcome and Quality of Life in Breast Cancer Patients
| Registry | NCT03104153 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 106 (Actual) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven (Other) |
| Conditions | Draining Wound, Breast Cancer |
| Interventions | Early-drain removal (Procedure) |
| Dates | start 2015-09-01, primary completion 2016-04-30, completion 2016-06-30, first posted 2017-04-07, last updated 2023-11-29 |
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All trials for Draining Wound All trials for Breast Cancer All trials of Early-drain removal
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Output-based | No intervention | ||
| Early-removal | Active comparator | Procedure: Early-drain removal |
Sex: All, ages: 18 Years to any
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