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Can a Pre-Surgery skin coating stop wound infections?

NCT ID NCT00940979

Prevention Sponsor: Rijnstate Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial tests whether applying a microbial sealant called Integuseal to the skin before leg bypass surgery can reduce postoperative wound infections. About 450 people scheduled for lower-limb arterial bypass procedures will be randomly assigned to receive the sealant or standard care. The study tracks infection rates, complications, and costs to see if this simple step offers a protective benefit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Integuseal, a microbial sealant applied to the skin before surgery
What this could lead to
If effective, this simple pre-surgery step could lower infection rates after leg bypass operations, reducing complications and healthcare costs.
What could go wrong
The trial is early and results may not show a clear benefit. Infections depend on many factors, so the sealant might not make a significant difference.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Jan 2010

Finished

May 2011

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Arterial Occlusive Diseases peripheral arterial disease Surgical Wound Infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arterial obstructive diseases

Contacts and locations

Locations

  • Ziekenhuis Nij Smellinghe

    Drachten, Netherlands

  • Ziekenhuis Rijnstate

    Arnhem, 6800 TA, Netherlands

  • Ziekenhuis Slingland

    Doetinchem, Netherlands

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