Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506311
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2007-07-23
Brief Title:
Evaluating the Use of Fibrin Tissue Adhesive in Melanoma Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Superficial Groin Dissection in Patients With Melanoma
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 MD Anderson Cancer Center and during drain removal
Follow-up wound exams will be performed by the local primary physician or in the MD 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
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 MD Anderson Cancer Center and during drain removal
Follow-up wound exams will be performed by the local primary physician or in the MD 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None