TYRX antibacterial envelope infection prophylaxis in spinal cord stimulation
Authors
Kristensen, Mathias Kirk Simoni ; Filtenborg, Jeppe Toft
Term
5. Term (Master thesis)
Education
Publication year
2022
Abstract
Baggrund: Rygmarvsstimulation (SCS) anvendes til behandling af kroniske smerter, men infektioner omkring den implanterbare pulsgenerator (IPG) er en væsentlig komplikation. En antibakteriel konvolut (TYRX) har reduceret infektionsrater ved hjertestimulatorer, men evidensen ved SCS er begrænset. Formål: At undersøge om TYRX-konvolutten reducerer postoperative infektioner ved SCS. Metode: Enkeltcenter, retrospektiv sammenligning af nye SCS-IPG-implantationer uden TYRX (2018-2020) versus med TYRX (2020-2021). Revisionskirurgi blev ekskluderet. Infektion blev defineret som postoperativ antibiotikabehandling inden for 100 dage. Gruppernes baseline (alder, BMI, rygning, diabetes, immunsuppression) blev sammenlignet, og infektionsrater blev testet med Fisher’s exact. Resultater: 198 patienter blev inkluderet (100 TYRX, 98 uden TYRX) med sammenlignelige baseline-karakteristika. Den samlede infektionsrate var 5,56%: 4,0% i TYRX-gruppen og 7,14% i ikke-TYRX-gruppen (p=0,6). Infektioner i TYRX-gruppen blev håndteret med peroral antibiotika alene, mens flere i ikke-TYRX-gruppen krævede intravenøs antibiotika, 4 revisionskirurgier og 3 eksplantationer. Diabetes var associeret med øget infektionsforekomst (p=0,04); der sås ingen association for rygning eller immunsuppression. En styrkeberegning estimerede behov for 856 patienter per gruppe for at påvise en signifikant forskel. Konklusion: TYRX viste en tendens til lavere infektionsrate og færre reinterventioner, men forskellen var ikke statistisk signifikant i dette underpowerede studie. Et større, prospektivt multicenterstudie anbefales.
Background: Spinal cord stimulation (SCS) treats chronic pain, but infections around the implantable pulse generator (IPG) remain an important complication. An antibacterial envelope (TYRX) has reduced infection rates in cardiac devices, but evidence in SCS is limited. Aim: To assess whether the TYRX envelope lowers postoperative infections in SCS. Methods: Single-center, retrospective comparison of new SCS IPG implants without TYRX (2018–2020) versus with TYRX (2020–2021). Revision surgeries were excluded. Infection was defined as postoperative antibiotic treatment within 100 days. Baseline characteristics (age, BMI, smoking, diabetes, immunosuppression) were compared, and infection rates were tested with Fisher’s exact. Results: 198 patients were included (100 TYRX, 98 non-TYRX) with comparable baselines. Overall infection rate was 5.56%: 4.0% in TYRX and 7.14% in non-TYRX (p=0.6). Infected TYRX recipients were managed with oral antibiotics only, whereas several non-TYRX patients required intravenous antibiotics, 4 revision surgeries, and 3 explants. Diabetes was associated with higher infection risk (p=0.04); no association was seen for smoking or immunosuppression. A power analysis indicated 856 patients per group would be needed to detect a significant difference. Conclusion: TYRX showed a trend toward fewer infections and reinterventions, but differences were not statistically significant in this underpowered study. A larger prospective multicenter study is warranted.
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