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

Rijnstate Hospital450 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

450

Conditions

Arterial Obstructive Diseases

Interventions

Application of Integuseal sealantPROCEDURE

Microbial sealant (integuseal) applied with a sponge applicator

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Ziekenhuis Rijnstate

Arnhem, Netherlands

Ziekenhuis Slingland

Doetinchem, Netherlands

Ziekenhuis Nij Smellinghe

Drachten, Netherlands

Outcomes

Primary Outcomes

Postoperative wound infections

Secondary Outcomes

Costs of the use of Integuseal

Complications during hospital stay

Data from ClinicalTrials.gov

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