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

Not Applicable

Terminated

• Conditions: Arterial Obstructive Diseases

• Registration Number: NCT00940979
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-16
• Study First Submitted QC: 2009-07-16
• Study First Posted: 2009-07-17
• Study Start: 2010-01
• Primary Completion: 2011-04
• Study Completion: 2011-05
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

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

Exclusion Criteria

• secondary procedures and suprainguinal procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative wound infections

Secondary Outcome Measures

Name	Time	Method
Costs of the use of Integuseal
Complications during hospital stay

Trial Locations

Locations (3)

Ziekenhuis Rijnstate; 🇳🇱 Arnhem, Netherlands

Ziekenhuis Slingland; 🇳🇱 Doetinchem, Netherlands

Ziekenhuis Nij Smellinghe; 🇳🇱 Drachten, Netherlands