Draining WoundNCT03104153
Effect of Early Removal of Wound Drains After Mastectomy or Lymph Node Dissection
A study testing Early-drain removal in people with Draining Wound and Breast Cancer, run by Universitaire Ziekenhuizen KU Leuven.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Draining Wound, Breast Cancer
- What is being tested?
- Early-drain removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to 30 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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
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
- Conditions
- Draining Wound, Breast Cancer
- Being tested
- Early-drain removal
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early-drain removalProcedure or surgery
Drain removal at hospital discharge
| Study group | Role | What they receive |
|---|---|---|
| Output-based | No intervention | Not described |
| Early-removal | Active comparator | Not described Receives: Procedure: Early-drain removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Improve the quality of life, wich will be measured by a questionnaire with some specific questions.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study startSep 2015
- Primary completion30 Apr 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Draining WoundStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104153
- Sponsor's protocol ID
- S58129
- Status last verified
- Mar 2017
- First submitted
- 27 Mar 2017
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03104153
- Acronym / sponsor ID
- S58129
- Conditions
- Draining Wound, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Output-based | No intervention | – |
| Early-removal | Active comparator | Procedure: Early-drain removal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early-drain removalDrain removal at hospital discharge | Procedure or surgery | Early-removal |
Primary outcome
Quality of Life
Time frame: 3 weeks
Improve the quality of life, wich will be measured by a questionnaire with some specific questions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Early-drain removal in people with Draining Wound and Breast Cancer, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.