An observational study in Malignant Melanoma, sponsored by Medical University of Graz. Completed at 1 site in Austria. Per ClinicalTrials.gov, last updated 2020-12-01.
Sponsored by Medical University of Graz · Observational
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 118 is below the median of 182 across 438 observational studies indexed under Melanoma.
Browse Melanoma studies →Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
daily drainage volume during hospitalization
The daily drainage amount durin hospital stay
Time frame: through study completion, an average of 1 year
total drainage volume during hospitalization
The total drainage amount during hospital stay
Time frame: through study completion, an average of 1 year
time-to-drain removal
The timepoint when the drain was removed
Time frame: through study completion, an average of 1 year
evacuation of seroma after drain removal
If evacuation of seroma after drain removal was needed
Time frame: through study completion, an average of 1 year
demographic data - age
age
Time frame: through study completion, an average of 1 year
demographic data - sex
sex
Time frame: through study completion, an average of 1 year
demographic data - BMI
body mass index (BMI)
Time frame: through study completion, an average of 1 year
demographic data - smoking
smoking
Time frame: through study completion, an average of 1 year
demographic data - Diabetes mellitus
diabetes mellitus
Time frame: through study completion, an average of 1 year
demographic data - allergies
allergies
Time frame: through study completion, an average of 1 year
intraoperative parameters
surgical procedure time
Time frame: through study completion, an average of 1 year
intraoperative parameters - site
site
Time frame: through study completion, an average of 1 year
Amount of histologically analyzed lymph nodes
The amount lymph nodes found at histological analysis
Time frame: 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
Time frame: through study completion, an average of 1 year
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Medical University of Graz