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Differences in wound complications when arterial access is accomplished through puncture of the artery compared to surgical cut down.

Percutaneous access in Endovascular Repair vs. Open repair

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26340
Enrollment
120
Registered
2013-11-10
Start date
2014-01-01
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Percutaneous Aneurysm Access Woundinfection

Interventions

Randomization between open surgical or percutaneous access in the common femoral artery. One patient with an indication for endovascular repair of an Aneurysm of the Abdominal Aorta (AAA) is operated

Sponsors

University Medical Center of Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with an AAA with a diameter of 55 millimeters or growth of 5 millimeters in half a year, suitable for endovascular repair.

Exclusion criteria

Exclusion criteria: history of operations of the common femoral artery. heavy calcifications in the common femoral artery. endovascular repair through less than 2 femoral incisions (monoïliacal device) or more than 2 femoral incisions (brachial or carotid)

Design outcomes

Primary

MeasureTime frame
Surgical site infections in the groin; 30 days postoperatively, and during a last control 1 year after operation. Wounds will be evaluated by means of the Southampton Wound Assessment score. When a surgical site infection is diagnosed, a wound-culture should confirm the bacterial contamination

Secondary

MeasureTime frame
wound complications in the groin; till 30 days postoperatively. Evaluated during wound assessment 2 days after surgery, 2 and 6 weeks after surgery. From all patients a nose-culture and a perineal culture will be obtained. When a surgical site infection occurs, correlation between cultures and SSI's will be drawn; till 30 days postoperatively. All patients score their wound-comfort in a VAS-score (visual analogue scale): till 6 weeks after surgery.

Contacts

Public ContactB.P. Vierhout

Europaweg-Zuid 1

bas.vierhout@wza.nl0592-325211

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)