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SiSi-trial.


- candidate number14104
- NTR NumberNTR3754
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-dec-2012
- Secondary IDs11-T-90 METC Atrium
- Public TitleSiSi-trial.
- Scientific TitlePREVENTION OF SURGICAL SITE INFECTION AT THE GROIN AFTER FEMORAL ARTERIAL EXPOSURE USING LOCAL GENTAMYCIN SPONGE.
- ACRONYMSiSi
- hypothesisThe main study parameter is the incidence of surgical site infections at the groin at day 30. A reduction of 50% is hypothesized.
- Healt Condition(s) or Problem(s) studiedFemoral arterial exposure
- Inclusion criteriaAll patients undergoing longitudinal femoral exposure for a vascular procedure of 18 years and older.
- Exclusion criteriaPatients 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2012
- planned closingdate31-dec-2013
- Target number of participants608
- InterventionsThe 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.
- Primary outcomeThe 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 outcomeIsolation of bacteria in colony forming units (CFU), length of hospital stay (LOS; in days), readmission, reoperation, antibiotics during hospital stay and at home (in days).
- Timepoints1. Pre-op;
2. Operation;
3. Day 1;
4. Discharge;
5. Week 2;
6. Week 4;
7. Week 6.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Marit Albada, van
- CONTACT for SCIENTIFIC QUERIES Bjorn Telgenkamp
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
Eusapharma
- PublicationsN/A
- Brief summaryRationale:
Despite the routine use of prophylactic systemic antibiotics, inguinal surgical site infection still occurs in 4-44[1-5]% 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 reconstruction.

Objective:
Primary endpoint: 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. The primary study comparison will be done in the intention-to-treat population.
Secondary endpoints: Creatinin, Leukocyte numbers and CRP, Isolation of bacteria in colony forming units (CFU), length of hospital stay (LOS; in days), readmission, reoperation, antibiotics during hospital stay and at home (in days).

Study design:
The study is designed as a prospective, randomized, controlled trial.

Study population:
All patients undergoing femoral exposure for a vascular procedure of 18 years and older. Excluding endovascular approach. 608 patients will be recruited.

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.

Main study parameters/endpoints:
The main study parameter is the incidence of surgical site infections at the groin at day 30. A reduction of 50% is hypothesized.
- Main changes (audit trail)
- RECORD17-dec-2012 - 4-jan-2013


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