Fibrin Sealant in Renal Transplantation

Completed · Not applicable

Conditions studied: Renal Transplantation

In brief

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.

Key facts

Study ID
NCT00910052
Run by
Hennepin County Medical Center, Minneapolis
People needed
141
Starts
2003-05-01
Expected to finish
2008-09-01
Last updated by the study team
2009-05-29

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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