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OpenTrials
Completed

NCT Number: NCT04648163

Suction Drain in Axillary Lymph Node Dissection for Malignant Melanoma

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.

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Key information

Conditions

Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz

Graz, Styria, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. daily drainage volume during hospitalization

    Time frame: through study completion, an average of 1 year

    The daily drainage amount durin hospital stay

  2. total drainage volume during hospitalization

    Time frame: through study completion, an average of 1 year

    The total drainage amount during hospital stay

  3. time-to-drain removal

    Time frame: through study completion, an average of 1 year

    The timepoint when the drain was removed

  4. 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

Secondary outcomes

  1. demographic data - age

    Time frame: through study completion, an average of 1 year

    age

  2. demographic data - sex

    Time frame: through study completion, an average of 1 year

    sex

  3. demographic data - BMI

    Time frame: through study completion, an average of 1 year

    body mass index (BMI)

  4. demographic data - smoking

    Time frame: through study completion, an average of 1 year

    smoking

  5. demographic data - Diabetes mellitus

    Time frame: through study completion, an average of 1 year

    diabetes mellitus

  6. demographic data - allergies

    Time frame: through study completion, an average of 1 year

    allergies

  7. intraoperative parameters

    Time frame: through study completion, an average of 1 year

    surgical procedure time

  8. intraoperative parameters - site

    Time frame: through study completion, an average of 1 year

    site

  9. Amount of histologically analyzed lymph nodes

    Time frame: through study completion, an average of 1 year

    The amount lymph nodes found at histological analysis

  10. 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

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 1, 2020
Registry last updated
Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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