Suction Drain in Axillary Lymph Node Dissection for Malignant Melanoma

NCT04648163 | Completed

• 1 other identifier: 29-607
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (4)

• daily drainage volume during hospitalization

  The daily drainage amount durin hospital stay

  through study completion, an average of 1 year

• total drainage volume during hospitalization

  The total drainage amount during hospital stay

  through study completion, an average of 1 year

• time-to-drain removal

  The timepoint when the drain was removed

  through study completion, an average of 1 year

• evacuation of seroma after drain removal

  If evacuation of seroma after drain removal was needed

  through study completion, an average of 1 year

Secondary Outcomes (10)

• demographic data - age

  through study completion, an average of 1 year

• demographic data - sex

  through study completion, an average of 1 year

• demographic data - BMI

  through study completion, an average of 1 year

• demographic data - smoking

  through study completion, an average of 1 year

• demographic data - Diabetes mellitus

  through study completion, an average of 1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

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

Study Officials

• David B Lumenta, MD, Prof

  Medical University of Graz

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: December 1, 2020
• Study Start: December 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 1, 2020

Record last verified: 2020-11

Locations

AU (1)