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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014