Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Melanoma

Seroma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Coagulants

All Drugs and Chemicals

Fibrin Tissue Adhesive

Hemostatics

Tisseel applied externally to the dissected axillary area.

Fibrin Sealant

Paul F. Mansfield, MD

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.

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.

Fibrin Melanoma Axillary Node Study in Patients With Melanoma

A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Axillary Node Dissection in Patients With Melanoma

Number of participants with any signs of infection noted following surgery requiring intervention.

M.D. Anderson Cancer Center

No data collected for the Questionnaire Only Arm, therefore no adverse events to report for the Questionnaire Only Arm.

Tisseel applied externally to the dissected axillary area. Intervention: Drug: Fibrin Sealant

Treatment Arm

Control Arm

Questionnaire Only

Total

Baseline characteristics not taken for the questionnaire only arm.

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Paul F Mansfield, Professor, Surgical Oncology

Data not collected for Questionnaire Only Arm.

Drain Duration

No data collected for Questionnaire Only Arm.

Number of Participants With Infection

Overall Study

Infections

Blood and Lymph Conditions

Communicable Diseases

Postoperative Complications

Lymphocele

Cysts

Lymphatic Diseases

Patients fron this group do not receive the fibrin sealant

Patients from this group will receive the fibrin sealant

The biological adhesive will be applied to the study group, with the spray technique in two atmospheres of pressure in a total amount of 10 ml.

Fibrin Glue

Alejandro Gonzalez-Ojeda, PhD

Globally there have been about 45,000 kidney transplants last year. Currently, the overall survival of renal transplant receptors is 95% in the first year and 85% at 5 years. A major challenge to overcome by the renal transplant surgeons, are surgical complications which may impact on patient morbidity and mortality, as well as graft function.

The aim of the study is to assess whether application of fibrin seal prevents postoperative complications in patients undergoing kidney transplantation.

Controlled clinical trial with single-blind evaluation in patients surgically intervened kidney transplantation. It will include all patients undergoing renal transplantation in this Medical Center, any gender and over than 16 years and under 60 years.

INTRODUCTION:

Globally there have been about 45,000 kidney transplants last year. Currently, the overall survival of renal transplant receptors is 95% in the first year and 85% at 5 years. A major challenge to overcome by the renal transplant surgeons, are surgical complications which may impact on patient morbidity and mortality, as well as graft function.

Since 2000 to date the specialties Hospital from the Western Medical Center of the Mexican Institute of Social Security, is the hospital where the greatest number of kidney transplants are performed, reporting to December 2005 a total of 990 cases, with an average of 200 transplants annually.

Since the completion of the first kidney transplants, there has emerged the presence of complications related to the surgical procedure, which have influenced the morbidity and mortality in transplant patients. Several factors are attributed to the occurrence of postoperative complications, such as the patient's nutritional status, ischemic time, presence of comorbidities, organ preservation, surgical technique, experience and skills of the surgeon and the postoperative care.

The main causes of complications in the kidney transplants are: urological complications such as urinary fistula, ureteral obstruction and ureteral necrosis (less than 7% of all kidney transplants). Ischemia is the most common probable cause of urological complications secondary to donor kidney extraction, anastomotic technique, variations in vascular supply, rejection or medication. Vascular complications as early arterial thrombosis, renal vein thrombosis and renal artery stenosis, are almost always due to a technical complication, or are accompanied by twisting or bending of blood vessels during placement of the transplanted kidney. Technical difficulties may be secondary to atherosclerotic disease in the donor or receptor, or interact with multiple arteries. Lymphatic complications as lymphocele and lymphatic fistula, after renal transplantation accumulation of lymphatic fluid postoperatively are up to 15% of the patients. It is believed that the origin of the lymph is in the destruction of perivascular normal lymph ducts during dissection, or destruction of the hilar lymph.

Decreasing the incidence of surgical wound infection after renal transplantation is multifactorial and is related to advances in the treatment of anemia, uremia, and general health of patients with end-stage renal disease.

The seals are partly fibrin blood products and pharmacological agents. Their specific use is as an adjunct to hemostasis as tissue adhesive. Seals are also developed as fibrin vehicle to provide antimicrobial pharmacological agents, chemotherapeutic agents and growth factors.

They have the advantage of being products of human origin without tissue toxicity, which promotes rapid fibrin seal. The seal is normally reabsorbed in days, promoting local tissue growth and repair without increasing perioperative development of adhesions.

OBJECTIVE:

Assess whether application of fibrin seal prevents postoperative complications in patients undergoing kidney transplantation.

MATERIAL AND METHODS:

Controlled clinical trial with single-blind evaluation in patients surgically intervened kidney transplantation. It will include all patients undergoing renal transplantation in this Medical Center, any gender and over than 16 years and under 60 years. Patients will be excluded with allergy to the fibrin glue components. All the transplant procedure will be made for the same surgical team.

The receptor site preparation will be done by addressing the retroperitoneal region of the right lower quadrant of the abdomen with an incision Gibson type.

The patients are going to be distributed into two groups: Group 1: fibrin, Group 2: Control. Complication weather vascular, urological, lymphatic, infectious, hospital stay and graft loss will be assessed.

The receptor site preparation will be done by addressing the retroperitoneal region of the right lower quadrant of the abdomen with an incision Gibson type.

The dissection of great vessels will be performed to achieve hemostasis of the blood vessels and nodes, with electrocoagulation and ligation gauge nonabsorbable 3-0.

The vascular anastomosis will be made to the external iliac vessels of the receptor in shaped end-side way, the suture material in size 6-0, in continuous sutures type with nonabsorbable monofilament. The new ureteral anastomosis will be performed with the modified technique of Leriche-Gregoire.

The new ureter will be tunneled and anastomosed to the mucosa with absorbable suture material 4-0 (polyglactin). The biological adhesive will be applied to the study group, with the spray technique in two atmospheres of pressure in a total amount of 10 ml. No biological adhesive, placebo or simulated technique will be performed to the control group.

There will be placed a continuous suction drainage of closed silicone type, and the abdominal wall will be closed with absorbable material in both groups.

Patients will be followed from the immediate postoperative period until discharge, and at follow up every week the first month, then every 15 days the second month, and monthly until one year follow up. During this follow-up, patients will be assessed through laboratory tests that include complete blood count, blood chemistry with serial measurements of serum creatinine, glomerular filtration rate, serum electrolytes and blood levels of immunosuppressants. Also patients will be followed from the clinical point of view and if there is any suspect for a complication, laboratory exams will be conducted such as crops, urinalysis, determination of creatinine, noninvasive imaging studies such as Doppler ultrasound, computed tomography, angiography if suspect on vascular complications.

STATISTICAL ANALYSIS:

Nominal variables were analyzed using percentage frequencies, X2 test or Fisher exact test. Numeric variables using Student's t test for independent samples and ANOVA with post hoc Scheffe test. U Mann Whitney and Kruskal Wallis tests will be used as long as data do not conform to normal distribution.

Fibrin Based Adhesive for the Prevention of Surgical Complications in the Kidney Transplantation

Application of the Biological Fibrin Based Adhesive for the Prevention of Surgical Complications in the Kidney Transplant

Patients will be followed from the immediate postoperative period until discharge, and at follow up every week the first month, then every 15 days the second month, and monthly until one year follow up. Identifying any kind of complication derived from the surgical procedure.

Identifying the different possible vascular postoperative complications:

* Renal artery stenosis: The narrowing of the light by 30% diagnosed by Doppler ecosonography and corroborated by arteriography.
* Renal vein stenosis: The narrowing of light\> 40% of the renal vein Doppler and confirmed by venography ecosonography graft.
* Arterial thrombosis: The total occlusion of the renal artery lumen by a thrombus, which prevents blood perfusion of the kidney, diagnosed by Doppler and arteriography of the graft.

Identifying the different possible urological postoperative complications:

* Urinary Fistula: The loss of continuity of the ureterovesical anastomosis with formation of a journey outward, allowing the escape of urine into the preperitoneal region at the site of graft placement.
* Ureteral obstruction: Stopping or reducing the passage of urine into the bladder through the ureter at the ureterovesical anastomosis, which is given by hyperplasia at the site.
* Ureteral necrosis: devitalization of the ureter as a result of devascularization, with loss of functionality and feasibility.

Identifying the different possible lymphatic postoperative complications:

* Lymphocele: encapsulated collection of lymphatic fluid in postoperative graft site.
* Lymphatic fistula: Leakage of lymph fluid with formation of a journey to the outside of the surgical wound.

Identifying the different possible infectious postoperative complications:

\*Surgical wound infection: Signs of wound infection, like redness, heat, increased local temperature and swelling of the wound. If the drain or treat this is limited, the subcutaneous tissue infection was considered superficial infection of the surgical site, if any collection of pus in the thickness of wound without involvement of the surgical wound abscess be known. If there is necrosis necrotizing myofasciitis be called.

Alejandro Gonzalez-Ojeda

Tisseel applied externally to the dissected groin area.

Janice N. Cormier, MD

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.

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.

Evaluating the Use of Fibrin Tissue Adhesive in Melanoma Patients

A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Superficial Groin Dissection in Patients With Melanoma

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fibrin Melanoma Axillary Node Study in Patients With Melanoma	NCT00504582	Melanoma	Fibrin Sealant	18 Years -	M.D. Anderson Cancer Center
Fibrin Based Adhesive for the Prevention of Surgical Complications in the Kidney Transplantation	NCT01631448	Vascular Postop... Urological Syst... Lymphocele Postoperative I...	Fibrin Glue	16 Years - 60 Years	Instituto Mexicano del Seguro Social
Evaluating the Use of Fibrin Tissue Adhesive in Melanoma Patients	NCT00506311	Melanoma	Fibrin Sealant	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for fibrin sealant