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OpenTrials
Completed

NCT Number: NCT00910052

Fibrin Sealant in Renal Transplantation

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All renal transplant recipients

Exclusion criteria

  • Patients declining study

Treatment and study plan

Tisseelä fibrin sealant

Device

Fibrin sealant applied intraoperatively

Primary outcomes

  1. presence of postoperative fluid collection

Secondary outcomes

  1. wound infection

  2. wound dehiscence

Sponsors and collaborators

Lead sponsor

Hennepin County Medical Center, Minneapolis

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2008
First posted
May 29, 2009
Registry last updated
May 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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