Fibrin Sealant in Renal Transplantation

Not Applicable

Completed

• Conditions: Renal Transplantation
• Interventions: Device: Tisseelä fibrin sealant

• Registration Number: NCT00910052
• Lead Sponsor: Hennepin County Medical Center, Minneapolis

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2006-05
• Study Completion: 2008-09
• Status Verified: 2009-05
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-28
• Last Update Submitted: 2009-05-28
• Study First Posted: 2009-05-29
• Last Update Posted: 2009-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

• All renal transplant recipients

Exclusion Criteria

• Patients declining study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fibrin sealant	Tisseelä fibrin sealant	received intraoperative fibrin sealant

Primary Outcome Measures

Name	Time	Method
presence of postoperative fluid collection

Secondary Outcome Measures

Name	Time	Method
wound infection
wound dehiscence

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States