The incidence of wound complications in endovascular aneurysm repair (EVAR). VAS scores will be obtained to objectify the advances of a percutaneous approach. Cultures and wound biopsies will be obtained from every patient. Also cost-effectiveness…
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the main study endpoint is the risk reduction of the number of surgical site
infections (SSI*s) after the use of percutaneous access compared to a surgical
cut-down for an EVAR.
Secondary outcome
Secondary endpoint is 1 year postoperatively. VAS scores and bacterial
contamination in wound infections will be evaluated.Cultures and biopsies are
used.
A correlation is sought between the cultures harvested from the nose and the
perineum.
Also cost-effectiveness is questioned in case of a significant difference
between the SSI-incidences.
Background summary
The Prostar XL device has proven a high rate of procedural success (1). Wound
complications were absent (2) or appeared in 0.7% (3) of the cases. In open
access procedures wound complications vary from 6.3% (www.prezies.nl) to 7.4%
(4).
Hypothesis: the Prostar XL device prevents wound complications in endovascular
aorta repair.
Study objective
The incidence of wound complications in endovascular aneurysm repair (EVAR).
VAS scores will be obtained to objectify the advances of a percutaneous
approach. Cultures and wound biopsies will be obtained from every patient. Also
cost-effectiveness will be studied, in case wound infections could be
prevented.
Study design
A randomised non-blinded clinical study with study groups that match perfectly:
for one patient needs two groin-incisions during the repair of an aneurysm of
the abdominal aorta (AAA). Randomisation consists of passage of the main device
of the endoprosthesis. The main device necessitates a larger access (20 french)
compared to the contralateral leg (12 french). Exclusion of patients treated
with a Nellix-device
Study burden and risks
Patients are required to fill out a VAS score form prior to and 2 weeks after
operation.
Cultures of the nose and the perineal region will be obtained during operation.
Punch biopsies are taken from the wound, one biopsy is used for culture
purposes, and the other biopsy for PA research. The patient will not notice
these activities.
In participating centres attention will be paid to the number of surgical site
infections in aorta surgery. There is evidence for reduction of surgical site
infections, when surgeons pay more attention to wound complications. Possibly
the patient will benefit from this investigation.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
Patients must be physically and mentally capable of giving consent for randomised femoral access and data storage,
in the possession of an aneurysm of the abdominal aorta with a diameter of at least 55 millimetres (or growth of 5 millimetres or more in half a years* time),
suitable for bifurcated endovascular repair through two femoral access sites, without additional access needed.
Exclusion criteria
Patients with extreme atherosclerosis (more than half (1/2) of the circumference of the CFA)
Previous common femoral artery surgery.
Patients treated with an aorto-monoiliacal device implanted, followed by a femorofemoral cross-over.
Patients in need for more than two femoral accesses (brachial or carotid).
Patients treated with a Nellie device (Endologics)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL44578.042.13 |
| OMON | NL-OMON26340 |