Malignant MelanomaNCT04648163
Suction Drain in Axillary Lymph Node Dissection for Malignant Melanoma
An observational study of Malignant Melanoma, run by Medical University of Graz at 1 site in Austria.
Trial summary
Postoperative complications like seroma formation and wound site infection readily occur following completion axillary lymph node dissection (ALND) for malignant melanoma. We analyzed the impact of time-to-drain removal and drainage volume on seroma formation after ALND. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Melanoma
- How many people
- 118 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2017to 1 Sep 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Included patients had a histologically confirmed malignant melanoma (MM), underwent axillary lymph node dissection (level I-III) and had daily drainage volume records over a two-week period. Prior data collection we obtained ethical approval (institutional review board #25-438 ex 12/13). Data collection and analysis were performed in accordance with the rules set by the Declaration of Helsinki.
Who may be able to join
- histologically confirmed malignant melanoma
- underwent axillary lymph node dissection (level I-III)
- daily drainage volume records over a two-week period available
Who cannot join
- daily drainage volume records over a two-week period not available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Suction Drain Volume Following Axillary Lymph Node Dissection for Malignant Melanoma - When to Remove Drains? A Retrospective Cohort Study.
Postoperative complications like seroma formation and wound site infection readily occur following completion axillary lymph node dissection (ALND) for malignant melanoma. We analyzed the impact of time-to-drain removal and drainage volume on seroma formation after ALND.
- Conditions
- Malignant Melanoma
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
daily drainage volume during hospitalization
The daily drainage amount durin hospital stay
Measured: through study completion, an average of 1 year
total drainage volume during hospitalization
The total drainage amount during hospital stay
Measured: through study completion, an average of 1 year
time-to-drain removal
The timepoint when the drain was removed
Measured: through study completion, an average of 1 year
evacuation of seroma after drain removal
If evacuation of seroma after drain removal was needed
Measured: through study completion, an average of 1 year
Secondary outcomes (10)
demographic data - age
age
Measured: through study completion, an average of 1 year
demographic data - sex
sex
Measured: through study completion, an average of 1 year
demographic data - BMI
body mass index (BMI)
Measured: through study completion, an average of 1 year
demographic data - smoking
smoking
Measured: through study completion, an average of 1 year
demographic data - Diabetes mellitus
diabetes mellitus
Measured: through study completion, an average of 1 year
demographic data - allergies
allergies
Measured: through study completion, an average of 1 year
intraoperative parameters
surgical procedure time
Measured: through study completion, an average of 1 year
intraoperative parameters - site
site
Measured: through study completion, an average of 1 year
Amount of histologically analyzed lymph nodes
The amount lymph nodes found at histological analysis
Measured: through study completion, an average of 1 year
Surgical complications
graded by the Clavien-Dindo-classification ( 1:normal postoperative cause without need of pharmacological treatment ; 2: pharmacological treatment ; 3: surgical, endoscooic or radiological treatment; 4: live-threating complications; 5: Death
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start1 Dec 2017
- Primary completion1 May 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David B Lumenta, MD, Prof, Study chair, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648163
- Sponsor's protocol ID
- 29-607
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suction Drain Volume Following Axillary Lymph Node Dissection for Malignant Melanoma - When to Remove Drains? A Retrospective Cohort Study.
- ClinicalTrials.gov ID
- NCT04648163
- Acronym / sponsor ID
- 29-607
- Conditions
- Malignant Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 1 Dec 2020 (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.
Postoperative complications like seroma formation and wound site infection readily occur following completion axillary lymph node dissection (ALND) for malignant melanoma. We analyzed the impact of time-to-drain removal and drainage volume on seroma formation after ALND.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Included patients had a histologically confirmed malignant melanoma (MM), underwent axillary lymph node dissection (level I-III) and had daily drainage volume records over a two-week period. Prior data collection we obtained ethical approval (institutional review board #25-438 ex 12/13). Data collection and analysis were performed in accordance with the rules set by the Declaration of Helsinki.
Key inclusion criteria (3 listed)
- histologically confirmed malignant melanoma
- underwent axillary lymph node dissection (level I-III)
- daily drainage volume records over a two-week period available
Key exclusion criteria (1 listed)
- daily drainage volume records over a two-week period not available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
daily drainage volume during hospitalization
Time frame: through study completion, an average of 1 year
The daily drainage amount durin hospital stay
total drainage volume during hospitalization
Time frame: through study completion, an average of 1 year
The total drainage amount during hospital stay
time-to-drain removal
Time frame: through study completion, an average of 1 year
The timepoint when the drain was removed
evacuation of seroma after drain removal
Time frame: through study completion, an average of 1 year
If evacuation of seroma after drain removal was needed
10 secondary outcomes
demographic data - age
Time frame: through study completion, an average of 1 year
demographic data - sex
Time frame: through study completion, an average of 1 year
demographic data - BMI
Time frame: through study completion, an average of 1 year
demographic data - smoking
Time frame: through study completion, an average of 1 year
demographic data - Diabetes mellitus
Time frame: through study completion, an average of 1 year
demographic data - allergies
Time frame: through study completion, an average of 1 year
intraoperative parameters
Time frame: through study completion, an average of 1 year
intraoperative parameters - site
Time frame: through study completion, an average of 1 year
Amount of histologically analyzed lymph nodes
Time frame: through study completion, an average of 1 year
Surgical complications
Time frame: through study completion, an average of 1 year
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 1 Dec 2020.
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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.
David B Lumenta, MD, Prof study chair
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Melanoma, run by Medical University of Graz at 1 site in Austria.
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 3 inclusion and 1 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 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
daily drainage volume during hospitalization (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. 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 1 Dec 2020.