Fibrin Sealant in Renal Transplantation

Status Completed

Clinical Trial Summary

Background: Post-operative wound complications arise in as many as 50% of kidney transplant recipients. Fibrin sealants have been used in many areas of surgery in attempt to reduce the accumulation of post-operative fluid collections with varying success. The use of fibrin products has been proposed as a means of reducing local wound complications in the immunocompromised renal transplant recipient but as yet has not been studied.

Methods: 145 patients were enrolled and 141 patients were randomized (74 Tisseelä fibrin sealant, 67 No Tisseelä fibrin sealant) in a prospective manner to receive fibrin sealant or not at the time of their renal transplant. Patients were analyzed per the randomization assignment. The operating team was blinded to the decision until after the iliac fossa dissection was complete. The sealant was applied via aerosol to the iliac fossa and renal allograft hilum after completion of the neoureterocystostomy in 5 ml quantity. Clinical and radiographic data were reviewed through the usual 8-week follow-up transplant ultrasound. Patients in whom the peritoneum was entered were excluded from data analysis. The incidence of lymphocele, wound infection, dehiscence, clinically significant hematoma as defined by necessitating incision and drainage, and urine leak was recorded.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Renal Transplantation

Clinical Trial Details

NCT number	NCT00910052
Study type	Interventional
Source	Hennepin County Medical Center, Minneapolis
Contact
Status	Completed
Phase	N/A
Start date	May 2003
Completion date	September 2008

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT06026592` - Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
Active, not recruiting	`NCT02444429` - 3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation	Phase 3
Completed	`NCT02238418` - Efficacy of Usual Vitamin D Supplementation and Its Impact on Children and Adolescents Calciuria.	Phase 4
Completed	`NCT01729494` - Belatacept Early Steroid Withdrawal Trial	Phase 4
Terminated	`NCT01436305` - Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation	Phase 2
Completed	`NCT02843295` - Catalytic Antibodies to Predict Uninvasively Late Transplant Failure	N/A
Terminated	`NCT01276834` - Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation	Phase 4
Completed	`NCT00842699` - Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab	N/A
Completed	`NCT00525681` - Interaction Between Rimonabant and Cyclosporine and Tacrolimus	Phase 4
Completed	`NCT00189735` - A Study to Evaluate FK778 in Kidney Transplant Patients	Phase 2
Completed	`NCT00776750` - Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients	Phase 4
Recruiting	`NCT04052867` - Intravenous Lignocaine Infusion in Laparoscopic Donor Nephrectomy	N/A
Recruiting	`NCT03114826` - Study of the Impact of VEGF Polymorphism on the Development of Renal Carcinoma in Renal Transplant Patients	N/A
Completed	`NCT02587052` - A 1-year Comparison of Generic Tacrolimus (Tacni) and Prograf in Renal Transplant Patients - a Retrospective Matched Pair Analysis, GenTac
Completed	`NCT02020642` - Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx)	N/A
Completed	`NCT01435291` - AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation	Phase 4
Recruiting	`NCT01001065` - Association of the Intrarenal Resistance Index (RI) of Transplanted Kidneys With Generalized Atherosclerosis	N/A
Completed	`NCT00978965` - Identification of Patients With High Probability of Poorly Responding to Therapy With Mycophenolic Acid Prodrugs
Recruiting	`NCT00903188` - Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation	Phase 4
Completed	`NCT00400400` - Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance	Phase 4