Suction Drain in Axillary Lymph Node Dissection for Malignant Melanoma

Completed

• Conditions: Malignant Melanoma

• Registration Number: NCT04648163
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-01
• Primary Completion: 2018-05-01
• Study Completion: 2018-09-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-04
• Study First Submitted QC: 2020-11-23
• Last Update Submitted: 2020-11-23
• Study First Posted: 2020-12-01
• Last Update Posted: 2020-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
daily drainage volume during hospitalization	through study completion, an average of 1 year	The daily drainage amount durin hospital stay
evacuation of seroma after drain removal	through study completion, an average of 1 year	If evacuation of seroma after drain removal was needed

Secondary Outcome Measures

Name	Time	Method
demographic data - Diabetes mellitus	through study completion, an average of 1 year	diabetes mellitus
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
demographic data - allergies	through study completion, an average of 1 year	allergies
intraoperative parameters - site	through study completion, an average of 1 year	site
demographic data - sex	through study completion, an average of 1 year	sex
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
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
Amount of histologically analyzed lymph nodes	through study completion, an average of 1 year	The amount lymph nodes found at histological analysis

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Styria, Austria