Renal TransplantationNCT00910052
Fibrin Sealant in Renal Transplantation
A study testing Tisseelä fibrin sealant in people with Renal Transplantation, run by Hennepin County Medical Center, Minneapolis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Tisseelä fibrin sealant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All renal transplant recipients
Who cannot join
- Patients declining study
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
Official title: Routine Use of Fibrin Sealant Does Not Reduce Postoperative Wound Complications in Patients Undergoing Renal Transplantation: A Randomized Controlled Trial
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.
- Conditions
- Renal Transplantation
- Being tested
- Tisseelä fibrin sealant
- Keywords
- randomised, controlled, double blinded
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tisseelä fibrin sealantDevice
Fibrin sealant applied intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| Fibrin sealant | Experimental | received intraoperative fibrin sealant Receives: Device: Tisseelä fibrin sealant |
| Control | No intervention | No fibrin sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of postoperative fluid collection
Secondary outcomes (2)
wound infection
wound dehiscence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startMay 2003
- Primary completionMay 2006
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin County Medical Center, Minneapolis
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910052
- Sponsor's protocol ID
- 20032206
- Status last verified
- May 2009
- First submitted
- 28 May 2009
- Last updated
- 29 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Use of Fibrin Sealant Does Not Reduce Postoperative Wound Complications in Patients Undergoing Renal Transplantation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00910052
- Acronym / sponsor ID
- 20032206
- Conditions
- Renal Transplantation
- Keywords
- randomised, controlled, double blinded
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Hennepin County Medical Center, MinneapolisUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- May 2006 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 29 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrin sealant | Experimental | Device: Tisseelä fibrin sealantreceived intraoperative fibrin sealant |
| Control | No intervention | –No fibrin sealant |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All renal transplant recipients
Key exclusion criteria (1 listed)
- Patients declining study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tisseelä fibrin sealantFibrin sealant applied intraoperatively | Device | Fibrin sealant |
Primary outcome
presence of postoperative fluid collection
2 secondary outcomes
wound infection
wound dehiscence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tisseelä fibrin sealant in people with Renal Transplantation, run by Hennepin County Medical Center, Minneapolis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of postoperative fluid collection. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2009.