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

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

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00940979

Acronym

ITT

Enrollment

450

Registered

2009-07-17

Start date

2010-01-01

Completion date

2011-05-01

Last updated

2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Obstructive Diseases

Keywords

Integuseal microbial sealant, Infection prophylaxis, Postoperative wound infection, Arterial bypass surgery

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.

Interventions

PROCEDUREApplication of Integuseal sealant

Microbial sealant (integuseal) applied with a sponge applicator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* secondary procedures and suprainguinal procedures

Design outcomes

Primary

Measure	Time frame
Postoperative wound infections	—

Secondary

Measure	Time frame
Costs of the use of Integuseal	—
Complications during hospital stay	—

Countries

Netherlands

Contacts

STUDY_DIRECTORMichel MPJ Reijnen, MD

Rijstate hospital Arnhem the Netherlands

STUDY_DIRECTORJ. Klinkenbijl, MD

PRINCIPAL_INVESTIGATORSjoerd A de Beer, MD

Rijnstate Hospital Arnhem the Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026