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Fibrin Sealant in Renal Transplantation

NCT ID: NCT00910052

Last Updated: 2009-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Transplantation

Keywords

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randomised controlled double blinded

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fibrin sealant

received intraoperative fibrin sealant

Group Type EXPERIMENTAL

Tisseelä fibrin sealant

Intervention Type DEVICE

Fibrin sealant applied intraoperatively

Control

No fibrin sealant

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tisseelä fibrin sealant

Fibrin sealant applied intraoperatively

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All renal transplant recipients

Exclusion Criteria

* Patients declining study
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hennepin County Medical Center, Minneapolis

OTHER

Sponsor Role lead

Locations

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Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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20032206

Identifier Type: -

Identifier Source: org_study_id