Prospective randomised trial using Integusealâ as microbial sealant for arterial bypass surgery on lower extremities

Postoperative woundinfections are responsible for approximately 25-38% of all
in-hospital infections that occur after surgery. A postoperative woundinfection
occurs in 2-5% of patients. The woundinfection rate after peripheral vascular
procedures is approximately 6%.
Due to these woundinfections, duration of treatment and hospital admission
increases and costs are higher.
This consequently increases the risk for other complications.
Infection prevention has become a big issue in surgery. Current measures to
prevent wound infections are asepsis of the operation area, antisepsis of the
surgeons hands, antimicrobial prophylaxis, management on the operation rooms,
operation techniques, but also postoperative woundcare. Besides these current
measures, in some clinics antiseptic impregnated incision foil is being used,
however it did not lead to a significant reduction in wouind infections.

A new technique using a microbial sealant (Integuseal) applicated
preoperatively with a sponge applicator, would have positive results on the
reduction of postoperatieve woundinfections.

This prospective randomised study has the primary objective 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. We aim at a reduction in wound infections of 50%.

Secundary we will study the costs of the use of Integuseal

Prospective randomised trial (comparable groups)
Population of 200 patients; 100 in the intervention study group and 100 in the
control group.
Conventional infection prevention measures versus conventional measures WITH
use of Integuseal preoperative.

Inclusion criteria: Planned arterial bypass procedure with autologue or
prosthetic graft at or below the groin (inguinal level). Operation classified
as 'clean' procedure following criteria of the US national research council
group.
Exclusion criteria: Secondary procedures or vascular procedures above the groin
(inguinal level)

Woundevaluation for wound infection will be done at postoperative day
2,4,6,8,10 and 14 accoring to the SOuthampton Wound Assessment Scale.

The last woundevaluation and the end of this study will be at two weeks after
hosptal dismission.

Costs of the use of Integuseal are being evaluated

Application of a layer of Integuseal (Cyanoacrylate) from a ready to use
applicator preoperative before incision. Polymerisation immobilises the
bacteries that survived the conventional skin preparation. This way there will
be less contamination of the wound.

Burden: a possible extra visit for woundevaluation when the patient is
dismissed within two weeks after surgery.
There will be no unnecessary hospitalisation en patients will not be witheld of
any conventional medical care.
So far no healththreatening risks are described of Integuseal