Clinical trial NCT00506311: Evaluating the Use of Fibrin Tissue Adhesive in Melanoma Patients
Official title: A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Superficial Groin Dissection in Patients With Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Keywords: Superficial Groin Dissection
Melanoma
Fibrin Tissue Adhesive
Fibrin Sealant
Tisseel
Seroma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2007-07-25
Enrollment: 53
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Patients in this study are scheduled to have groin 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 groin 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.

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 after the 6-week follow-up.

This is an investigational study. The sealant is FDA approved, though its use in this study is experimental. About 58 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility criteria: Inclusion Criteria:

* Part I - Inclusion Criteria Patients that consent to participate.
* 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.
* Part II- Inclusion Criteria Patients that consent to participate.
* Patients with melanoma for which a superficial node dissection is indicated (with or without a concurrent deep (ilioinguinal) node dissection.

Exclusion Criteria:

* Part II - Exclusion Criteria Patients with known hypersensitivity to bovine proteins.
* 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.

Primary outcomes:
measure: Time-to-Drain Removal
timeFrame: From surgery to 30 days post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: U.T.M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Janice N. Cormier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.