NCT00910052

Fibrin Sealant in Renal Transplantation

Routine Use of Fibrin Sealant Does Not Reduce Postoperative Wound Complications in Patients Undergoing Renal Transplantation: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Hennepin County Medical Center, Minneapolis · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DEVICE	Tisseelä fibrin sealant	Fibrin sealant applied intraoperatively

Timeline

• Start date: 2003-05-01
• Primary completion: 2006-05-01
• Completion: 2008-09-01
• First posted: 2009-05-29
• Last updated: 2009-05-29

Locations

1 site across 1 country: United States