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

Arterial Obstructive Diseases Clinical Trial

— ITT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00940979
• Other study ID #: LTC 625-230609
• Status: Terminated
• Phase: N/A
• First received: July 16, 2009
• Last updated: January 10, 2014
• Start date: January 2010
• Est. completion date: May 2011

Study information

• Verified date: January 2014
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 450
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• secondary procedures and suprainguinal procedures

Study Design

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

Related Conditions & MeSH terms

• Arterial Obstructive Diseases
• Arterial Occlusive Diseases

Intervention

Procedure:
• Application of Integuseal sealant
Microbial sealant (integuseal) applied with a sponge applicator

Locations

Country	Name	City	State
Netherlands	Ziekenhuis Rijnstate	Arnhem
Netherlands	Ziekenhuis Slingland	Doetinchem
Netherlands	Ziekenhuis Nij Smellinghe	Drachten

Sponsors (2)

Lead Sponsor	Collaborator
Rijnstate Hospital	Kimberly-Clark Corporation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative wound infections
Secondary	Costs of the use of Integuseal
Secondary	Complications during hospital stay