MedTrace Logo

Fibrin Based Adhesive for the Prevention of Surgical Complications in the Kidney Transplantation

NCT01631448 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2015-03-24

No results posted yet for this study

Summary

Globally there have been about 45,000 kidney transplants last year. Currently, the overall survival of renal transplant receptors is 95% in the first year and 85% at 5 years. A major challenge to overcome by the renal transplant surgeons, are surgical complications which may impact on patient morbidity and mortality, as well as graft function.

The aim of the study is to assess whether application of fibrin seal prevents postoperative complications in patients undergoing kidney transplantation.

Controlled clinical trial with single-blind evaluation in patients surgically intervened kidney transplantation. It will include all patients undergoing renal transplantation in this Medical Center, any gender and over than 16 years and under 60 years.

Conditions

  • Vascular Postoperative Complications
  • Urological System Complication of Procedure
  • Lymphocele
  • Postoperative Infection

Interventions

BIOLOGICAL

Fibrin Glue

The biological adhesive will be applied to the study group, with the spray technique in two atmospheres of pressure in a total amount of 10 ml.

Sponsors & Collaborators

  • Alejandro Gonzalez-Ojeda

    lead OTHER_GOV

Principal Investigators

  • Alejandro Gonzalez-Ojeda, PhD · Instituto Mexicano del Seguro Social

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2014-01-31
Completion
2014-03-31

Countries

  • Mexico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01631448 on ClinicalTrials.gov