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

This study is not yet open for participant recruitment.

Verified August 2011 by Rijnstate Hospital

Sponsor:

Collaborator:

Kimberly-Clark Corporation

Information provided by:

Rijnstate Hospital

ClinicalTrials.gov Identifier:

NCT00940979

First received: July 16, 2009

Last updated: August 8, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 16, 2009

Last Updated Date

August 8, 2011

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Postoperative wound infections

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00940979 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Costs of the use of Integuseal
Complications during hospital stay

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Condition ^ICMJE

Arterial Obstructive Diseases

Intervention ^ICMJE

Procedure: Application of Integuseal sealant

Microbial sealant (integuseal) applied with a sponge applicator

Study Arm (s)

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.

Intervention: Procedure: Application of Integuseal sealant

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

450

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

secondary procedures and suprainguinal procedures

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sjoerd A de Beer, MD

026378888

sdebeer@alysis.nl

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00940979

Other Study ID Numbers ^ICMJE

LTC 625-230609

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Rijnstate Hospital

Collaborators ^ICMJE

Kimberly-Clark Corporation

Investigators ^ICMJE

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

Information Provided By

Rijnstate Hospital

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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