Fibrin Sealant in Renal Transplantation

Renal Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910052
• Other study ID #: 20032206
• Status: Completed
• Phase: N/A
• First received: May 28, 2009
• Last updated: May 28, 2009
• Start date: May 2003
• Est. completion date: September 2008

Study information

• Verified date: May 2009
• Source: Hennepin County Medical Center, Minneapolis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: September 2008
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All renal transplant recipients

Exclusion Criteria:

• Patients declining study

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

Intervention

Device:
• Tisseelä fibrin sealant
Fibrin sealant applied intraoperatively

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Hennepin County Medical Center, Minneapolis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of postoperative fluid collection
Secondary	wound infection
Secondary	wound dehiscence