NCT00940979

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

January 13, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

July 16, 2009

Last Update Submit

January 10, 2014

Conditions

Arterial Obstructive Diseases

Keywords

Integuseal microbial sealantInfection prophylaxisPostoperative wound infectionArterial bypass surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative wound infections

Secondary Outcomes (2)

  • Costs of the use of Integuseal

  • Complications during hospital stay

Study Arms (2)

No use of integuseal

NO INTERVENTION

Use of Integuseal

EXPERIMENTAL

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

Interventions

Application of Integuseal sealantPROCEDURE

Microbial sealant (integuseal) applied with a sponge applicator

Use of Integuseal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • secondary procedures and suprainguinal procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ziekenhuis Rijnstate

Arnhem, 6800 TA, Netherlands

Location

Ziekenhuis Slingland

Doetinchem, Netherlands

Location

Ziekenhuis Nij Smellinghe

Drachten, Netherlands

Location

MeSH Terms

Conditions

Arterial Occlusive DiseasesSurgical Wound Infection

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesWound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michel MPJ Reijnen, MD

    Rijstate hospital Arnhem the Netherlands

    STUDY DIRECTOR

  • J. Klinkenbijl, MD

    STUDY DIRECTOR

  • Sjoerd A de Beer, MD

    Rijnstate Hospital Arnhem the Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 16, 2009

First Posted

July 17, 2009

Study Start

January 1, 2010

Primary Completion

April 1, 2011

Study Completion

May 1, 2011

Last Updated

January 13, 2014

Record last verified: 2014-01

Locations

NL(3)