NCT00910052

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 29, 2009

Completed
Last Updated

May 29, 2009

Status Verified

May 1, 2009

Enrollment Period

3 years

First QC Date

May 28, 2009

Last Update Submit

May 28, 2009

Conditions

Renal Transplantation

Keywords

randomisedcontrolleddouble blinded

Outcome Measures

Primary Outcomes (1)

  • presence of postoperative fluid collection

Secondary Outcomes (2)

  • wound infection

  • wound dehiscence

Study Arms (2)

Fibrin sealant

EXPERIMENTAL

received intraoperative fibrin sealant

Device: Tisseelä fibrin sealant

Control

NO INTERVENTION

No fibrin sealant

Interventions

Tisseelä fibrin sealantDEVICE

Fibrin sealant applied intraoperatively

Fibrin sealant

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All renal transplant recipients

You may not qualify if:

  • Patients declining study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2009

First Posted

May 29, 2009

Study Start

May 1, 2003

Primary Completion

May 1, 2006

Study Completion

September 1, 2008

Last Updated

May 29, 2009

Record last verified: 2009-05

Locations

US(1)