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

This study has been terminated.
(Interim analyses showed insufficient result. Termination for reasons of futility)
Sponsor:
Collaborator:
Kimberly-Clark Corporation
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT00940979
First received: July 16, 2009
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Arterial Obstructive Diseases
Procedure: Application of Integuseal sealant

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Prospective Randomised Trial Using Integuseal as Microbial Sealant for Arterial Bypass Surgery on Lower Extremities

Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:
  • Postoperative wound infections

Secondary Outcome Measures:
  • Costs of the use of Integuseal
  • Complications during hospital stay

Estimated Enrollment: 450
Study Start Date: January 2010
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • secondary procedures and suprainguinal procedures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940979

Locations
Netherlands
Ziekenhuis Rijnstate
Arnhem, Netherlands, 6800 TA
Ziekenhuis Slingland
Doetinchem, Netherlands
Ziekenhuis Nij Smellinghe
Drachten, Netherlands
Sponsors and Collaborators
Rijnstate Hospital
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00940979     History of Changes
Other Study ID Numbers: LTC 625-230609
Study First Received: July 16, 2009
Last Updated: January 10, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Rijnstate Hospital:
Integuseal microbial sealant
Infection prophylaxis
Postoperative wound infection
Arterial bypass surgery

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014