Improving Case Selection for Perioperative S. Aureus Transmission Surveillance to Reduce Surgical Site Infections
6 juillet 2021 mis à jour par: Randy Loftus
The first patient in the dyad will receive the bundle, which includes patient decolonization methods, environmental cleaning in the OR, a hand hygiene system located on the IV pole for the anesthesia provider, and intravascular catheter and syringe tip disinfection practices.
The second patient in the dyad will receive usual care.
Both patients will be surveyed by obtaining swab samples at the beginning and end of the surgery using the OR PathTrac kits.
The OR PathTrac software (RDB Bioinformatics, Omaha, NE 68154) uses algorithms to guide analysis of the S. aureus isolates and to identify transmission events.
Transmission stories are processed by the software to generate transmission maps that identify improvement successes and failures.
It also identifies actionable steps to improve the bundle.
The perioperative infection control team then uses this information to continually optimize the bundle, and the software to measure the effect.
Aperçu de l'étude
Statut
Retiré
Les conditions
Intervention / Traitement
Description détaillée
Surgical site infections increase patient morbidity and healthcare costs. The Centers for Disease Control and Prevention emphasizes improved basic preventive measures to reduce bacterial transmission and infections for patients undergoing surgery.
Patients undergoing planned oncologic gynecological and plastic surgery will be entered as dyads into a worksheet each day that will rank and select the optimal cases. The research assistants consent both patients in the dyad to the study while they are in the Day of Surgery Admissions area. The first patient in the dyad will receive the bundle, which includes patient decolonization methods, environmental cleaning in the OR, a hand hygiene system located on the IV pole for the anesthesia provider, and intravascular catheter and syringe tip disinfection practices. The second patient in the dyad will receive usual care. Both patients will be surveyed by obtaining swab samples at the beginning and end of the surgery using the OR PathTrac kits. The OR PathTrac kits are obtained from and analyzed for S. aureus isolates by RDB Bioinformatics. The OR PathTrac software (RDB Bioinformatics, Omaha, NE 68154) uses algorithms to guide analysis of the S. aureus isolates and to identify transmission events. Transmission stories are processed by the software to generate transmission maps that identify improvement successes and failures. It also identifies actionable steps to improve the bundle. The perioperative infection control team then uses this information to continually optimize the bundle, and the software to measure the effect.
Type d'étude
Observationnel
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Iowa
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Iowa City, Iowa, États-Unis, 52242
- University of Iowa
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 120 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Patients scheduled to undergo oncologic gynecological and plastic surgery requiring general/regional anesthesia.
La description
Inclusion Criteria:
- Patients scheduled to undergo oncologic gynecological and plastic surgery requiring general/regional anesthesia.
- informed, written consent.
Exclusion Criteria:
- Patients <18 years of age.
- Patients scheduled to undergo procedures outside of the surgical service lines listed above.
- Patients not requiring general or regional anesthesia.
- Patients who have a documented allergy or have an allergic reaction to to iodine, shellfish, or chlorhexidine.
- Patients who have not provided informed, written consent.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
First patient in the case pair
This patient will receive the treatment bundle.
S. aureus transmission surveillance will be conducted.
|
Patient decolonization within one hour of incision, improved environmental cleaning (frequency and quality, including but not limited to targeted use of no touch disinfection with UV-C treatment), provider hand hygiene leveraging proximity, improved catheter disinfection, and surveillance optimization.
|
|
Second patient in the case pair
This patient will receive usual care.
S. aureus transmission surveillance will be conducted.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time course in S. aureus transmission decline with the intervention.
Délai: Up to 52 weeks
|
S. aureus transmission events by time.
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Up to 52 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Systematic selection of sequential cases in operating rooms for surveillance to reduce sample size and increase power.
Délai: Up to 52 weeks
|
The outcome is the proportional reduction in the necessary sample size of pairs of cases achieved by systematic selection of sample cases as compared with random selection.
|
Up to 52 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Randy W Loftus, MD, University of Iowa
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Stulberg JJ, Delaney CP, Neuhauser DV, Aron DC, Fu P, Koroukian SM. Adherence to surgical care improvement project measures and the association with postoperative infections. JAMA. 2010 Jun 23;303(24):2479-85. doi: 10.1001/jama.2010.841.
- Loftus RW, Koff MD, Brown JR, Patel HM, Jensen JT, Reddy S, Ruoff KL, Heard SO, Yeager MP, Dodds TM. The epidemiology of Staphylococcus aureus transmission in the anesthesia work area. Anesth Analg. 2015 Apr;120(4):807-18. doi: 10.1213/ANE.0b013e3182a8c16a.
- Loftus RW, Dexter F, Robinson ADM. High-risk Staphylococcus aureus transmission in the operating room: A call for widespread improvements in perioperative hand hygiene and patient decolonization practices. Am J Infect Control. 2018 Oct;46(10):1134-1141. doi: 10.1016/j.ajic.2018.04.211. Epub 2018 Jun 12.
- Loftus RW, Dexter F, Robinson ADM, Horswill AR. Desiccation tolerance is associated with Staphylococcus aureus hypertransmissibility, resistance and infection development in the operating room. J Hosp Infect. 2018 Nov;100(3):299-308. doi: 10.1016/j.jhin.2018.06.020. Epub 2018 Jun 30.
- Koff MD, Loftus RW, Burchman CC, Schwartzman JD, Read ME, Henry ES, Beach ML. Reduction in intraoperative bacterial contamination of peripheral intravenous tubing through the use of a novel device. Anesthesiology. 2009 May;110(5):978-85. doi: 10.1097/ALN.0b013e3181a06ec3.
- Loftus RW, Brown JR, Koff MD, Reddy S, Heard SO, Patel HM, Fernandez PG, Beach ML, Corwin HL, Jensen JT, Kispert D, Huysman B, Dodds TM, Ruoff KL, Yeager MP. Multiple reservoirs contribute to intraoperative bacterial transmission. Anesth Analg. 2012 Jun;114(6):1236-48. doi: 10.1213/ANE.0b013e31824970a2. Epub 2012 Mar 30.
- Loftus RW, Brindeiro BS, Kispert DP, Patel HM, Koff MD, Jensen JT, Dodds TM, Yeager MP, Ruoff KL, Gallagher JD, Beach ML, Brown JR. Reduction in intraoperative bacterial contamination of peripheral intravenous tubing through the use of a passive catheter care system. Anesth Analg. 2012 Dec;115(6):1315-23. doi: 10.1213/ANE.0b013e31826d2aa4. Epub 2012 Nov 9.
- Clark C, Taenzer A, Charette K, Whitty M. Decreasing contamination of the anesthesia environment. Am J Infect Control. 2014 Nov;42(11):1223-5. doi: 10.1016/j.ajic.2014.07.016. Epub 2014 Oct 30.
- German RR, Lee LM, Horan JM, Milstein RL, Pertowski CA, Waller MN; Guidelines Working Group Centers for Disease Control and Prevention (CDC). Updated guidelines for evaluating public health surveillance systems: recommendations from the Guidelines Working Group. MMWR Recomm Rep. 2001 Jul 27;50(RR-13):1-35; quiz CE1-7.
- Wilson AP, Smyth D, Moore G, Singleton J, Jackson R, Gant V, Jeanes A, Shaw S, James E, Cooper B, Kafatos G, Cookson B, Singer M, Bellingan G. The impact of enhanced cleaning within the intensive care unit on contamination of the near-patient environment with hospital pathogens: a randomized crossover study in critical care units in two hospitals. Crit Care Med. 2011 Apr;39(4):651-8. doi: 10.1097/CCM.0b013e318206bc66.
- Loftus RW, Dexter F, Robinson ADM. Methicillin-resistant Staphylococcus aureus has greater risk of transmission in the operating room than methicillin-sensitive S aureus. Am J Infect Control. 2018 May;46(5):520-525. doi: 10.1016/j.ajic.2017.11.002. Epub 2018 Jan 4.
- Robinson ADM, Dexter F, Renkor V, Reddy S, Loftus RW. Operating room PathTrac analysis of current intraoperative Staphylococcus aureus transmission dynamics. Am J Infect Control. 2019 Oct;47(10):1240-1247. doi: 10.1016/j.ajic.2019.03.028. Epub 2019 Apr 27.
- Schweizer ML, Chiang HY, Septimus E, Moody J, Braun B, Hafner J, Ward MA, Hickok J, Perencevich EN, Diekema DJ, Richards CL, Cavanaugh JE, Perlin JB, Herwaldt LA. Association of a bundled intervention with surgical site infections among patients undergoing cardiac, hip, or knee surgery. JAMA. 2015 Jun 2;313(21):2162-71. doi: 10.1001/jama.2015.5387.
- Phillips M, Rosenberg A, Shopsin B, Cuff G, Skeete F, Foti A, Kraemer K, Inglima K, Press R, Bosco J. Preventing surgical site infections: a randomized, open-label trial of nasal mupirocin ointment and nasal povidone-iodine solution. Infect Control Hosp Epidemiol. 2014 Jul;35(7):826-32. doi: 10.1086/676872. Epub 2014 May 21.
- Rubin RH. Surgical wound infection: epidemiology, pathogenesis, diagnosis and management. BMC Infect Dis. 2006 Nov 27;6:171. doi: 10.1186/1471-2334-6-171.
- Dexter F, Ledolter J, Epstein RH, Loftus RW. Importance of operating room case scheduling on analyses of observed reductions in surgical site infections from the purchase and installation of capital equipment in operating rooms. Am J Infect Control. 2020 May;48(5):566-572. doi: 10.1016/j.ajic.2019.08.017. Epub 2019 Oct 19.
- Dexter F, Epstein RH, Gostine AL, Penning DH, Loftus RW. Benefit of systematic selection of pairs of cases matched by surgical specialty for surveillance of bacterial transmission in operating rooms. Am J Infect Control. 2020 Jun;48(6):682-687. doi: 10.1016/j.ajic.2019.09.025. Epub 2019 Nov 1.
- Wang H, Hong S, Liu Y, Duan Y, Yin H. High inspired oxygen versus low inspired oxygen for reducing surgical site infection: a meta-analysis. Int Wound J. 2017 Feb;14(1):46-52. doi: 10.1111/iwj.12548. Epub 2015 Dec 23.
- Durkin MJ, Dicks KV, Baker AW, Lewis SS, Moehring RW, Chen LF, Sexton DJ, Anderson DJ. Seasonal Variation of Common Surgical Site Infections: Does Season Matter? Infect Control Hosp Epidemiol. 2015 Sep;36(9):1011-6. doi: 10.1017/ice.2015.121. Epub 2015 May 26.
- Munoz-Price LS, Bowdle A, Johnston BL, Bearman G, Camins BC, Dellinger EP, Geisz-Everson MA, Holzmann-Pazgal G, Murthy R, Pegues D, Prielipp RC, Rubin ZA, Schaffzin J, Yokoe D, Birnbach DJ. Infection prevention in the operating room anesthesia work area. Infect Control Hosp Epidemiol. 2019 Jan;40(1):1-17. doi: 10.1017/ice.2018.303. Epub 2018 Dec 11. No abstract available. Erratum In: Infect Control Hosp Epidemiol. 2019 Apr;40(4):500.
- Anderson DJ, Chen LF, Weber DJ, Moehring RW, Lewis SS, Triplett PF, Blocker M, Becherer P, Schwab JC, Knelson LP, Lokhnygina Y, Rutala WA, Kanamori H, Gergen MF, Sexton DJ; CDC Prevention Epicenters Program. Enhanced terminal room disinfection and acquisition and infection caused by multidrug-resistant organisms and Clostridium difficile (the Benefits of Enhanced Terminal Room Disinfection study): a cluster-randomised, multicentre, crossover study. Lancet. 2017 Feb 25;389(10071):805-814. doi: 10.1016/S0140-6736(16)31588-4. Epub 2017 Jan 17.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
9 mars 2020
Achèvement primaire (Anticipé)
1 août 2021
Achèvement de l'étude (Anticipé)
1 août 2021
Dates d'inscription aux études
Première soumission
2 mars 2020
Première soumission répondant aux critères de contrôle qualité
6 mars 2020
Première publication (Réel)
9 mars 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 juillet 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 juillet 2021
Dernière vérification
1 juillet 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 201911589
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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Description du régime IPD
Data will be shared upon written request and reviewed by the principal investigator for consideration.
Délai de partage IPD
Upon request and evaluation, if approved by the PI for release, at least one year from publication date.
Critères d'accès au partage IPD
Submitted research protocol approved by the principal investigator, Dr. Loftus
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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