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Fibrin Melanoma Axillary Node Study in Patients With Melanoma

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ClinicalTrials.gov Identifier: NCT00504582
Recruitment Status : Active, not recruiting
First Posted : July 20, 2007
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Fibrin Sealant Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Axillary Node Dissection in Patients With Melanoma
Actual Study Start Date : May 2002
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Fibrin Sealant
Tisseel applied externally to the dissected axillary area.
Drug: Fibrin Sealant
Tisseel applied externally to the dissected axillary area.
Other Name: Tisseel

No Intervention: No Fibrin Sealant



Primary Outcome Measures :
  1. Use of TISSEEL (adhesive substance) to decrease the rate of seroma (fluid build-up) at the site of surgery, thus decreasing the time it takes before the drain can be removed. [ Time Frame: 8 Years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Part I - Inclusion Criteria, patients that consent to participate.
  2. 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504582


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Paul F. Mansfield, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00504582     History of Changes
Other Study ID Numbers: GS01-565
NCI-2012-01524 ( Registry Identifier: NCI CTRP )
First Posted: July 20, 2007    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017

Keywords provided by M.D. Anderson Cancer Center:
Axillary Node Dissection
Fibrin Sealant
Tisseel
Melanoma
Seroma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Fibrin Tissue Adhesive
Hemostatics
Coagulants