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

Rijnstate Hospital

Status: Terminated

Conditions: Arterial Obstructive Diseases

Treatments: Procedure: Application of Integuseal sealant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00940979

LTC 625-230609

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• secondary procedures and suprainguinal procedures

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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450 participants in 2 patient groups

No use of integuseal

No Intervention group

Use of Integuseal

Experimental group

Description:

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.

Treatment:

Procedure: Application of Integuseal sealant