Suction Drain in Axillary Lymph Node Dissection for Malignant Melanoma

November 23, 2020 updated by: Medical University of Graz

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.

Study Overview

Status

Completed

Conditions

Malignant Melanoma

Study Type

Observational

Enrollment (Actual)

118

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- Styria
  - Graz, Styria, Austria, 8036
    - Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
daily drainage volume during hospitalization Time Frame: through study completion, an average of 1 year	The daily drainage amount durin hospital stay	through study completion, an average of 1 year
total drainage volume during hospitalization Time Frame: through study completion, an average of 1 year	The total drainage amount during hospital stay	through study completion, an average of 1 year
time-to-drain removal Time Frame: through study completion, an average of 1 year	The timepoint when the drain was removed	through study completion, an average of 1 year
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	through study completion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

Study Chair: David B Lumenta, MD, Prof, Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 23, 2020

First Posted (Actual)

December 1, 2020

Study Record Updates

Last Update Posted (Actual)