Fibrin Sealant in Renal Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00910052
Recruitment Status : Completed
First Posted : May 29, 2009
Last Update Posted : May 29, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Renal Transplantation Device: Tisseelä fibrin sealant Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Routine Use of Fibrin Sealant Does Not Reduce Postoperative Wound Complications in Patients Undergoing Renal Transplantation: A Randomized Controlled Trial
Study Start Date : May 2003
Actual Primary Completion Date : May 2006
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Fibrin sealant
received intraoperative fibrin sealant
Device: Tisseelä fibrin sealant
Fibrin sealant applied intraoperatively
No Intervention: Control
No fibrin sealant

Primary Outcome Measures :
  1. presence of postoperative fluid collection

Secondary Outcome Measures :
  1. wound infection
  2. wound dehiscence

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All renal transplant recipients

Exclusion Criteria:

  • Patients declining study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00910052

United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Hennepin County Medical Center, Minneapolis Identifier: NCT00910052     History of Changes
Other Study ID Numbers: 20032206
First Posted: May 29, 2009    Key Record Dates
Last Update Posted: May 29, 2009
Last Verified: May 2009

Keywords provided by Hennepin County Medical Center, Minneapolis:
double blinded

Additional relevant MeSH terms:
Fibrin Tissue Adhesive