The aim of this study is to test the hypothesis that a gentamicin-collagen sponge reduces the incidence of surgical site infection (SSI) in patients undergoing inguinal dissection for vascular disease
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The incidence of surgical site infection (SSI), including prosthetic graft
infection classified according to Szilagyi, through 30 days postoperatively by
a committee blinded to study allocation
Secondary outcome
Length of the incision (measured postoperatively and photographed).
Quantitative microbial count of skin flora immediately post-incision between
two treatment groups when purulent fluid evacuates from the wound. (Isolation
of bacteria in colony forming units (CFU))
Creatinine, Leukocyte numbers and CRP measured at day 1 post-operative, at
discharge and at 2 weeks.
Bypass patency was confirmed by noninvasive hemodynamic Doppler studies on the
first postoperative day and by duplex 6 weeks after index operation.
Postoperative complications are recorded.
Length of hospital stay.
Re-admission and reoperation.
Use of intravenous or oral antibiotic during hospital stay and at home
Background summary
Despite the routine use of prophylactic systemic antibiotics, inguinal surgical
site infection still occurs in 4-44% in patients undergoing femoral exposure
for central or peripheral arterial disease and is associated with significant
excess morbidity, mortality, and costs. A large, 2-center, randomized trial in
Sweden reported in 2005 that a gentamicin-collagen sponge, a surgically
implantable topical antibiotic, reduced surgical site infection by 50% in
patients undergoing cardiac bypass surgery.
The aim of this study is to test the hypothesis that a gentamicin-collagen
sponge reduces the incidence of surgical site infection (SSI) in patients
undergoing inguinal dissection for vascular
Study objective
The aim of this study is to test the hypothesis that a gentamicin-collagen
sponge reduces the incidence of surgical site infection (SSI) in patients
undergoing inguinal dissection for vascular disease
Study design
The study is designed as a prospective, randomized, controlled trial
Intervention
The study arm will receive the implantable gentamicin collagen sponge and the
control arm will not receive a sponge at the end of the vascular procedure
before closing the groin
Study burden and risks
1 extra visit to the out-patient clinic
possible allergic reaction to gentamicin
possible reduction of woundinfections
Henri Dunantstraat 5
6419 PC, Heerlen
NL
Henri Dunantstraat 5
6419 PC, Heerlen
NL
Listed location countries
Age
Inclusion criteria
All patients undergoing femoral incision for primary arterial repair.
Patients are 18 years or older, and both sexes can participate.
Signed informed consent
Exclusion criteria
Patients known with a sensitivity or allergy to gentamicin.
Patients pregnant or breast feeding.
In case of bilateral groin dissection for vascular surgery, the left groin is excluded.
Patients undergoing femoral incision for endovascular procedures
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-001786-40-NL |
| CCMO | NL36728.096.11 |