Clinical trial NCT04648163: Suction Drain in Axillary Lymph Node Dissection for Malignant Melanoma
Official title: Suction Drain Volume Following Axillary Lymph Node Dissection for Malignant Melanoma - When to Remove Drains? A Retrospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Melanoma
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 118
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed malignant melanoma
* underwent axillary lymph node dissection (level I-III)
* daily drainage volume records over a two-week period available

Exclusion Criteria:

* daily drainage volume records over a two-week period not available

Primary outcomes:
measure: daily drainage volume during hospitalization
timeFrame: through study completion, an average of 1 year
measure: total drainage volume during hospitalization
timeFrame: through study completion, an average of 1 year
measure: time-to-drain removal
timeFrame: through study completion, an average of 1 year
measure: evacuation of seroma after drain removal
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: demographic data - age
timeFrame: through study completion, an average of 1 year
measure: demographic data - sex
timeFrame: through study completion, an average of 1 year
measure: demographic data - BMI
timeFrame: through study completion, an average of 1 year
measure: demographic data - smoking
timeFrame: through study completion, an average of 1 year
measure: demographic data - Diabetes mellitus
timeFrame: through study completion, an average of 1 year
measure: demographic data - allergies
timeFrame: through study completion, an average of 1 year
measure: intraoperative parameters
timeFrame: through study completion, an average of 1 year
measure: intraoperative parameters - site
timeFrame: through study completion, an average of 1 year
measure: Amount of histologically analyzed lymph nodes
timeFrame: through study completion, an average of 1 year
measure: Surgical complications
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: David B Lumenta, MD, Prof
role: STUDY_CHAIR
References: