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Terminated

NCT Number: NCT00940979

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

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.

Why the study stopped: Interim analyses showed insufficient result. Termination for reasons of futility
Terminated

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Key information

Conditions

Arterial Obstructive Diseases Arterial Occlusive Diseases Cardiovascular Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Vascular Diseases Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Rijnstate, Arnhem, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • secondary procedures and suprainguinal procedures

Treatment and study plan

Application of Integuseal sealant

Procedure

Microbial sealant (integuseal) applied with a sponge applicator

Primary outcomes

  1. Postoperative wound infections

Secondary outcomes

  1. Costs of the use of Integuseal

  2. Complications during hospital stay

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Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Collaborators

  • Kimberly-Clark Corporation

Registry information

Official study title

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

Acronym: ITT

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 17, 2009
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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