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Completed

NCT Number: NCT00504582

Fibrin Melanoma Axillary Node Study in Patients With Melanoma

Primary Objective:

* To determine whether the use of a fibrin sealant applied to axillary soft tissues following node dissection can result in earlier drain removal.

Secondary Objectives:

* To determine the postoperative morbidity rate using fibrin sealant following axillary node dissection. * To assess patient-valuation of outcome by performing a cost-benefit analysis using a willingness-to-pay model. * To determine if serum levels, lymphatic fluids level, or cutaneous expression of vascular endothelial growth factor-D (VEGF-D), vascular endothelial growth factor-C (VEGF-C) or their receptor, vascular endothelial growth factor receptor-3 (VEGFR-3) correlates with nodal tumor burden or development of lymphedema in patients with melanoma.

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Key information

Conditions

Melanoma Inflammation Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathologic Processes Pathological Conditions, Signs and Symptoms Seroma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

Patients in this study are scheduled to have axillary node dissection as part of their surgery for treatment of their melanoma.

Within 2 weeks before entry into the study, patients will have a complete physical exam and medical history.

These patients will be randomly assigned (as in the toss of a coin) to one of two groups. Patients in one group will receive TISSEEL applied externally to the dissected axillary area. Patients in the other group will receive no fibrin sealant.

For patients who are admitted to the hospital, the surgical site will be monitored by the surgeon for evidence of wound complications in the first 24 hours after surgery. At the time of discharge from the hospital, patients will be instructed in drain care and how to measure the drainage each day until the drain is removed.

The contents of the drain will be collected from patients during the first day after surgery, during the first return follow-up visit to M.D. Anderson Cancer Center, and during drain removal (unless these latter 2 dates are the same).

Follow-up wound exams will be performed by the local primary physician or in the M.D. Anderson Melanoma Clinic between 1-4 weeks and 6 weeks after surgery. Participation will be over at the 6-week follow-up.

THIS IS AN INVESTIGATIONAL STUDY. The sealant is FDA approved, though its use in this study is experimental. About 115 patients will take part in this study. All will be enrolled at M. D. Anderson.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Part I - Inclusion Criteria, patients that consent to participate.
  • Patients with melanoma who have undergone axillary dissection within the last six months as part of their surgical treatment will be considered for the study.

Exclusion criteria

  • Part II - Exclusion Criteria, patients with known hypersensitivity to bovine proteins.
  • Patient has undergone prior radiation therapy to the operative site.
  • Patient is pregnant or lactating.
  • Patient is steroid dependent within prior 6 months.
  • Patient has used aspirin or other anti-platelet drug (excluding Celebrex) within seven days of operation.
  • Patient has pre-existing lymphedema.
  • Patient has other pre-existing medical conditions with evidence of organ dysfunction as determined by principal investigator.

Treatment and study plan

Fibrin Sealant

Drug

Tisseel applied externally to the dissected axillary area.

Other names: Tisseel

Primary outcomes

  1. Drain Duration

    Time frame: from surgery until drain removed, up to 40 days

    Number of days drain was in place

Secondary outcomes

  1. Number of Participants With Infection

    Time frame: after surgery until the wound is healed, up to 30 days whichever is longer

    Number of participants with any signs of infection noted following surgery requiring intervention.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Axillary Node Dissection in Patients With Melanoma

Important dates

Study start
2002
Primary completion
2020
Study completion
2020
First posted
Jul 20, 2007
Registry last updated
May 9, 2023

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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