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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00940979
Recruitment Status : Terminated (Interim analyses showed insufficient result. Termination for reasons of futility)
First Posted : July 17, 2009
Last Update Posted : January 13, 2014
Kimberly-Clark Corporation
Information provided by:
Rijnstate Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Arterial Obstructive Diseases Procedure: Application of Integuseal sealant Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Prospective Randomised Trial Using Integuseal as Microbial Sealant for Arterial Bypass Surgery on Lower Extremities
Study Start Date : January 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : May 2011

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

Primary Outcome Measures :
  1. Postoperative wound infections

Secondary Outcome Measures :
  1. Costs of the use of Integuseal
  2. Complications during hospital stay

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • secondary procedures and suprainguinal procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00940979

Ziekenhuis Rijnstate
Arnhem, Netherlands, 6800 TA
Ziekenhuis Slingland
Doetinchem, Netherlands
Ziekenhuis Nij Smellinghe
Drachten, Netherlands
Sponsors and Collaborators
Rijnstate Hospital
Kimberly-Clark Corporation
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 Identifier: NCT00940979     History of Changes
Other Study ID Numbers: LTC 625-230609
First Posted: July 17, 2009    Key Record Dates
Last Update Posted: January 13, 2014
Last Verified: January 2014

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