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

Primary Purpose

Arterial Obstructive Diseases

Status

Terminated

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Application of Integuseal sealant

About this trial

This is an interventional prevention trial for Arterial Obstructive Diseases focused on measuring Integuseal microbial sealant, Infection prophylaxis, Postoperative wound infection, Arterial bypass surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

secondary procedures and suprainguinal procedures

Sites / Locations

Ziekenhuis Rijnstate
Ziekenhuis Slingland
Ziekenhuis Nij Smellinghe

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No use of integuseal

Use of Integuseal

Arm Description

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.

Outcomes

Primary Outcome Measures

Postoperative wound infections

Secondary Outcome Measures

Costs of the use of Integuseal

Complications during hospital stay

Full Information

NCT ID

NCT00940979

First Posted

July 16, 2009

Last Updated

January 10, 2014

Sponsor

Rijnstate Hospital

Collaborators

Kimberly-Clark Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00940979

Brief Title

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

Acronym

ITT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Terminated

Why Stopped

Interim analyses showed insufficient result. Termination for reasons of futility

Study Start Date

January 2010 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Rijnstate Hospital

Collaborators

Kimberly-Clark Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arterial Obstructive Diseases

Keywords

Integuseal microbial sealant, Infection prophylaxis, Postoperative wound infection, Arterial bypass surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

No use of integuseal

Arm Type

No Intervention

Arm Title

Use of Integuseal

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Application of Integuseal sealant

Intervention Description

Microbial sealant (integuseal) applied with a sponge applicator

Primary Outcome Measure Information:

Title

Postoperative wound infections

Secondary Outcome Measure Information:

Title

Costs of the use of Integuseal

Title

Complications during hospital stay

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: planned supragenual of infragenual peripheral arterial bypass procedures with autologue or prosthetic graft Exclusion Criteria: secondary procedures and suprainguinal procedures

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michel MPJ Reijnen, MD

Organizational Affiliation

Rijstate hospital Arnhem the Netherlands

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

J. Klinkenbijl, MD

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Sjoerd A de Beer, MD

Organizational Affiliation

Rijnstate Hospital Arnhem the Netherlands

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ziekenhuis Rijnstate

City

Arnhem

ZIP/Postal Code

6800 TA

Country

Netherlands

Facility Name

Ziekenhuis Slingland

City

Doetinchem

Country

Netherlands

Facility Name

Ziekenhuis Nij Smellinghe

City

Drachten

Country

Netherlands

12. IPD Sharing Statement

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

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