T82.7
Conditions
Interventions
Group 1: Patients treated in Dutch hospitals regarding breast or vascular implants.
Group 2: Patients treated in German hospitals regarding breast or vascular implants.
Sponsors
Cross-Border Institute of the Carl von Ossietzky Universität Oldenburg and University Medical Centre Groningen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Retrospective analysis Inclusion criteria VGEI: All male and female patients 18 years and older who developed VGEI between 2009 and 2022, which was confirmed by either microbiological culture, imaging or surgical findings will be included. BI: All patients 18 years and older who developed BII between 2009 and 2022 at the participating hospitals (either after partial mastectomy for breast cancer, or following preventive mastectomy) will be included. Both patients with SSI after primary BI and secondary BI (in which a two-stage method is used: firstly, a tissue expander is placed and a breast implant in a secondary surgery) will be included. Prospective analysis Twenty health care professionals from different health complexities, including: vascular surgeons, gynaecologists performing breast implant surgery, plastic surgeons and operating staff. Inclusion criteria: performing or supporting VGE/BI surgery in one of our participating hospitals.
Exclusion criteria
Exclusion criteria: Retrospective analysis: Exclusion criteria All patients who are registered in the objection register. VGEI: Patients who presented with infected arteriovenous shunts or arterial patches at initial surgery will be excluded. Also, patients with an initial vascular reconstruction because of primary inflammatory aneurysms or primary aortoenteric fistulae will not be included, since these grafts are implemented in infectious sites and therefore at higher infectious risk. BI: In patients that present with one infected breast implant and want the implant preventively removed, the preventively removed implant will not be included. Prospective analysis: Exclusion criteria: health care professionals that performed or supported their last VGE/BI surgery more than 3 years ago (for that they have to be relatively up to date with the latest SOPs).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the incidence of early and late surgical site infections following breast implant and vascular graft and endograft surgery in the Ems-Dollart region | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are: 1. Microorganisms involved in breast implant and vascular graft infections and antibiotic resistance patterns 2. Used treatment modalities and the surgical outcome of implant infections 3. Differences in protocols, guidelines and Standard Operating Protocols for patients undergoing breast implant and vascular graft surgery 4. The perspective of health care professionals on the prevention of surgical site infections 5. Recommendations given by health care professionals on prevention of implant infections | — |
Countries
Germany, Netherlands
Contacts
Public ContactAdriana Pérez Fortis
Faculty of Economics and Business Aletta Jacobs School of Public Health — Management
Outcome results
None listed