Fibrin Melanoma Axillary Node Study in Patients With Melanoma

NCT00504582 | Completed Results

• 2 other identifiers: GS01-565NCI-2012-01524
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma

Keywords

Axillary Node Dissection; Fibrin Sealant; Tisseel; Melanoma; Seroma

Outcome Measures

Primary Outcomes (1)

• Drain Duration

  Number of days drain was in place

  from surgery until drain removed, up to 40 days

Secondary Outcomes (1)

• Number of Participants With Infection

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

Study Arms (2)

Fibrin Sealant

EXPERIMENTAL

Tisseel applied externally to the dissected axillary area.

Drug: Fibrin Sealant

No Fibrin Sealant

NO INTERVENTION

Interventions

Fibrin Sealant DRUG

Tisseel applied externally to the dissected axillary area.

Also known as: Tisseel

Fibrin Sealant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Melanoma; Seroma

Interventions

Fibrin Tissue Adhesive

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; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Paul F Mansfield, Professor, Surgical Oncology
• Organization: UT MD Anderson Cancer Center

pmansfie@mdanderson.org

(713) 794-5499

Study Officials

• Paul F. Mansfield, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 20, 2007
• Study Start: May 15, 2002
• Primary Completion: April 9, 2020
• Study Completion: April 9, 2020
• Last Updated: May 9, 2023
• Results First Posted: October 26, 2021

Record last verified: 2023-04

Locations

US (1)