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NCT00910052 · ClinicalTrials.gov registry record · NA
Fibrin Sealant in Renal Transplantation
A NA study, sponsored by Hennepin County Medical Center, Minneapolis.
- Completed
- Registry status
- NA
- Development phase
- 141
- Enrollment target
NCT00910052 is a NA study that has completed, run by Hennepin County Medical Center, Minneapolis. The registered enrollment target is 141 participants.
The verdict
NCT00910052, a NA study, has completed, sponsored by Hennepin County Medical Center, Minneapolis.
- COMPLETED
- Registry status
- NA
- Development phase
- 141 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Tisseelä fibrin sealant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2003-05 |
| Est. Completion | 2008-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00910052
The ClinicalTrials.gov registry entry for NCT00910052 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hennepin County Medical Center, Minneapolis, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tisseelä fibrin sealant is the first listed.
NCT00910052 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00910052 about?
NCT00910052 is a clinical study titled "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...
What is the current status of trial NCT00910052?
This trial is currently completed. It is a NA study. The enrollment target is 141 participants. The study started on 2003-05. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00910052?
The interventions under investigation include: Tisseelä fibrin sealant (DEVICE).
Who is sponsoring clinical trial NCT00910052?
This trial is sponsored by Hennepin County Medical Center, Minneapolis, which has 3 total clinical trials registered on ClinicalTrials.gov.
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