Evaluating the Use of Fibrin Tissue Adhesive in Melanoma Patients

NCT00506311 | Completed

• 1 other identifier: GS01-564
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: 1\. To determine whether the use of a fibrin sealant applied to superficial groin soft tissues following node dissection can result in decreased cumulative postoperative drainage, earlier drain removal, and lower incidence of seroma. Secondary Objectives:

1. 1.To determine the postoperative morbidity rate using fibrin sealant following superficial groin dissection.
2. 2.To assess patient-valuation of outcome by performing a cost-benefit analysis using a willingness-to-pay model.
3. 3.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

Superficial Groin Dissection; Melanoma; Fibrin Tissue Adhesive; Fibrin Sealant; Tisseel; Seroma

Outcome Measures

Primary Outcomes (1)

• Time-to-Drain Removal

  The superficial groin drain will be removed once cumulative serous drainage volume 30 ml / 24 hours for 2 days or maximum of = or \< 30 days has elapsed since surgery. Time calculated as days from installation of drain at first day of surgery to removal.

  From surgery to 30 days post surgery

Study Arms (2)

Fibrin Sealant

EXPERIMENTAL

Drug: Fibrin Sealant

No Fibrin Sealant

NO INTERVENTION

Interventions

Fibrin Sealant DRUG

Tisseel applied externally to the dissected groin area.

Also known as: Tisseel

Fibrin Sealant

Eligibility Criteria

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

You may qualify if:

• Patients with melanoma who have undergone superficial node dissection (with or without a concurrent deep (ilioinguinal) node dissection within the last six months as part of their surgical treatment will be considered for the study.
• Patients with melanoma for which a superficial node dissection is indicated (with or without a concurrent deep (ilioinguinal) node dissection.

You may not qualify if:

• Patient has undergone prior radiation therapy to the operative site (groin).
• Patient is pregnant or lactating.
• Patient is steroid dependent within last 6 months.
• Patient has used aspirin or other anti-platelet drug (excluding Celebrex) within seven days of operation.
• Patients with pre-existing lymphedema.
• Patients with other pre-existing medical conditions as per the discretion of the principal investigator.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Bayer: collaborator

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Mortenson MM, Xing Y, Weaver S, Lee JE, Gershenwald JE, Lucci A, Mansfield PF, Ross MI, Cormier JN. Fibrin sealant does not decrease seroma output or time to drain removal following inguino-femoral lymph node dissection in melanoma patients: a randomized controlled trial (NCT00506311). World J Surg Oncol. 2008 Jun 18;6:63. doi: 10.1186/1477-7819-6-63.

  PMID: 18564433 DERIVED

Related Links

• UT MD Anderson Cancer Center

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

Study Officials

• Janice N. Cormier, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

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 23, 2007
• First Posted: July 25, 2007
• Study Start: February 1, 2003
• Primary Completion: December 1, 2007
• Study Completion: March 1, 2008
• Last Updated: August 2, 2012

Record last verified: 2012-08

Locations

US (1)