Fibrin Sealant in Renal Transplantation
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Purpose
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 | Intervention |
|---|---|
|
Renal Transplantation |
Device: Tisseelä fibrin sealant |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
- presence of postoperative fluid collection
- wound infection
- wound dehiscence
| Enrollment: | 141 |
| Study Start Date: | May 2003 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fibrin sealant
received intraoperative fibrin sealant
|
Device: Tisseelä fibrin sealant
Fibrin sealant applied intraoperatively
|
|
No Intervention: Control
No fibrin sealant
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All renal transplant recipients
Exclusion Criteria:
- Patients declining study
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00910052 History of Changes |
| Other Study ID Numbers: | 20032206 |
| Study First Received: | May 28, 2009 |
| Last Updated: | May 28, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Hennepin County Medical Center, Minneapolis:
|
randomised controlled double blinded |
Additional relevant MeSH terms:
|
Fibrin Tissue Adhesive Hemostatics Coagulants |
Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013