Suction Drain in Axillary Lymph Node Dissection for Malignant Melanoma

Suction Drain Volume Following Axillary Lymph Node Dissection for Malignant Melanoma - When to Remove Drains? A Retrospective Cohort Study.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04648163

Enrollment

118

Registered

2020-12-01

Start date

2017-12-01

Completion date

2018-09-01

Last updated

2020-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Melanoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
daily drainage volume during hospitalization	through study completion, an average of 1 year	The daily drainage amount durin hospital stay
total drainage volume during hospitalization	through study completion, an average of 1 year	The total drainage amount during hospital stay
time-to-drain removal	through study completion, an average of 1 year	The timepoint when the drain was removed
evacuation of seroma after drain removal	through study completion, an average of 1 year	If evacuation of seroma after drain removal was needed

Secondary

Measure	Time frame	Description
demographic data - Diabetes mellitus	through study completion, an average of 1 year	diabetes mellitus
demographic data - allergies	through study completion, an average of 1 year	allergies
intraoperative parameters	through study completion, an average of 1 year	surgical procedure time
demographic data - age	through study completion, an average of 1 year	age
Amount of histologically analyzed lymph nodes	through study completion, an average of 1 year	The amount lymph nodes found at histological analysis
Surgical complications	through study completion, an average of 1 year	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
intraoperative parameters - site	through study completion, an average of 1 year	site
demographic data - sex	through study completion, an average of 1 year	sex
demographic data - BMI	through study completion, an average of 1 year	body mass index (BMI)
demographic data - smoking	through study completion, an average of 1 year	smoking

Countries

Austria

Outcome results