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Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM)

NCT00713661 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2012-05-08

Study results available
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Summary

The primary objective is to evaluate if the application of TachoSil® on a colorectal anastomosis is feasible and safe.

The secondary objective is to establish and describe optimal application methods to be used for educational purposes in future trials.

Conditions

  • Colorectal Anastomosis

Interventions

DRUG

TachoSil®

Sterile, ready-to-use, absorbable sponge for intra-operative topical application. It consists of an equine collagen sponge coated with the fibrin glue components human fibrinogen and human thrombin. Surgery was performed according to the hospitals' local standards. When the anastomosis was performed, all enrolled subjects had TachoSil® applied around the anastomotic line. TachoSil® was therefore an add-on therapy.

Sponsors & Collaborators

  • Nycomed

    lead INDUSTRY

Principal Investigators

  • Nycomed Clinical Trial Operations · Headquarters

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-06-30
Completion
2010-07-31

Countries

  • Germany
  • Netherlands
  • United Kingdom

Study Locations

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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 NCT00713661 on ClinicalTrials.gov