Arterial Obstructive DiseasesITTNCT00940979
Trial Using Integuseal as Microbial Sealant for Arterial Bypass Surgery on Lower Extremities
A study testing Application of Integuseal sealant in people with Arterial Obstructive Diseases, run by Rijnstate Hospital at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Obstructive Diseases
- What is being tested?
- Application of Integuseal sealant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 3 sitesNetherlands
- Study dates
- Jan 2010to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planned supragenual of infragenual peripheral arterial bypass procedures with autologue or prosthetic graft
Who cannot join
- secondary procedures and suprainguinal procedures
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Ziekenhuis Rijnstate
Arnhem, 6800 TA
Ziekenhuis Slingland
Doetinchem
Ziekenhuis Nij Smellinghe
Drachten
About this study
Official title: Prospective Randomised Trial Using Integuseal as Microbial Sealant for Arterial Bypass Surgery on Lower Extremities
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.
- Conditions
- Arterial Obstructive Diseases
- Being tested
- Application of Integuseal sealant
- Keywords
- Integuseal microbial sealant, Infection prophylaxis, Postoperative wound infection, Arterial bypass surgery
- Medical subject headings
- Arterial Occlusive Diseases, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of Integuseal sealantProcedure or surgery
Microbial sealant (integuseal) applied with a sponge applicator
| Study group | Role | What they receive |
|---|---|---|
| No use of integuseal | No intervention | Not described |
| Use of Integuseal | Experimental | 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. Receives: Procedure: Application of Integuseal sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative wound infections
Secondary outcomes (2)
Costs of the use of Integuseal
Complications during hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startJan 2010
- Primary completionApr 2011
- Study completionMay 2011
Why it stopped: Interim analyses showed insufficient result. Termination for reasons of futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Obstructive DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kimberly-Clark Corporation
- Responsible party
- Sponsor
- Investigators
- Michel MPJ Reijnen, MD, Study director, Rijstate hospital Arnhem the NetherlandsJ. Klinkenbijl, MD, Study directorSjoerd A de Beer, MD, Principal investigator, Rijnstate Hospital Arnhem the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940979
- Sponsor's protocol ID
- LTC 625-230609
- Acronym
- ITT
- Status last verified
- Aug 2026
- First submitted
- 16 Jul 2009
- Last updated
- 13 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Trial Using Integuseal as Microbial Sealant for Arterial Bypass Surgery on Lower Extremities
- ClinicalTrials.gov ID
- NCT00940979
- Acronym / sponsor ID
- ITT / LTC 625-230609
- Conditions
- Arterial Obstructive Diseases
- Keywords
- Integuseal microbial sealant, Infection prophylaxis, Postoperative wound infection, Arterial bypass surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analyses showed insufficient result. Termination for reasons of futility
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Kimberly-Clark Corporation
- Study start
- Jan 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 17 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No use of integuseal | No intervention | – |
| Use of Integuseal | Experimental | Procedure: Application of Integuseal sealantApplication 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- planned supragenual of infragenual peripheral arterial bypass procedures with autologue or prosthetic graft
Key exclusion criteria (1 listed)
- secondary procedures and suprainguinal procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of Integuseal sealantMicrobial sealant (integuseal) applied with a sponge applicator | Procedure or surgery | Use of Integuseal |
Primary outcome
Postoperative wound infections
2 secondary outcomes
Costs of the use of Integuseal
Complications during hospital stay
Results and safety
The study was stopped early (reason given: Interim analyses showed insufficient result. Termination for reasons of futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel MPJ Reijnen, MD study director
Rijstate hospital Arnhem the Netherlands
J. Klinkenbijl, MD study director
Sjoerd A de Beer, MD principal investigator
Rijnstate Hospital Arnhem the Netherlands
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of Integuseal sealant in people with Arterial Obstructive Diseases, run by Rijnstate Hospital at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Interim analyses showed insufficient result. Termination for reasons of futility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative wound infections. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.