Trial Using Integuseal as Microbial Sealant for Arterial Bypass Surgery on Lower Extremities (ITT)

January 10, 2014 updated by: Rijnstate Hospital

Prospective Randomised Trial Using Integuseal as Microbial Sealant for Arterial Bypass Surgery on Lower Extremities

The purpose of this study is to prove a reduction of postoperative wound infections after direct preoperative use of a microbial sealant in the form of Integuseal for vascular procedures on lower extremities.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Arnhem, Netherlands, 6800 TA
        • Ziekenhuis Rijnstate
      • Doetinchem, Netherlands
        • Ziekenhuis Slingland
      • Drachten, Netherlands
        • Ziekenhuis Nij Smellinghe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • planned supragenual of infragenual peripheral arterial bypass procedures with autologue or prosthetic graft

Exclusion Criteria:

  • secondary procedures and suprainguinal procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No use of integuseal
Experimental: Use of Integuseal
Application of a layer of Integuseal (Cyanoacrylate) from a ready to use applicator preoperative before incision Polymerisation immobilise the bacteria that survived the conventional skin preparation This way there will be les contamination of the wound.
Procedure: Application of Integuseal sealant
Microbial sealant (integuseal) applied with a sponge applicator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Postoperative wound infections

Secondary Outcome Measures

Outcome Measure
Costs of the use of Integuseal
Complications during hospital stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Collaborators

Kimberly-Clark Corporation

Investigators

  • Study Director: Michel MPJ Reijnen, MD, Rijstate hospital Arnhem the Netherlands
  • Study Director: J. Klinkenbijl, MD
  • Principal Investigator: Sjoerd A de Beer, MD, Rijnstate Hospital Arnhem the Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

July 16, 2009

First Submitted That Met QC Criteria

July 16, 2009

First Posted (Estimate)

July 17, 2009

Study Record Updates

Last Update Posted (Estimate)

January 13, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTC 625-230609

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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