Fibrin Sealant in Renal Transplantation

This study has been completed.
Sponsor:
Information provided by:
Hennepin County Medical Center, Minneapolis
ClinicalTrials.gov Identifier:
NCT00910052
First received: May 28, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted

May 28, 2009
May 28, 2009
May 2003
May 2006   (final data collection date for primary outcome measure)
presence of postoperative fluid collection
Same as current
No Changes Posted
  • wound infection
  • wound dehiscence
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Renal Transplantation
Device: Tisseelä fibrin sealant
Fibrin sealant applied intraoperatively
  • Experimental: Fibrin sealant
    received intraoperative fibrin sealant
    Intervention: Device: Tisseelä fibrin sealant
  • No Intervention: Control
    No fibrin sealant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
141
September 2008
May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All renal transplant recipients

Exclusion Criteria:

  • Patients declining study
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00910052
20032206
Yes
Not Provided
Hennepin County Medical Center, Minneapolis
Not Provided
Not Provided
Hennepin County Medical Center, Minneapolis
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP