O.Zmora1 · Y. Stark2  · O. Belotserkovsky2  · M. Reichert2  · G. A. Kozloski2  · N. Wasserberg3  · H. Tulchinsky4  · L. Segev5  · A.J. Senagore2 · N. Emanuel2

Received: 11 May 2022 / Accepted: 16 August 2022 / Published online: 1 September 2022

© The Author(s) 2022

A. J. Senagore

该Email地址已收到反垃圾邮件插件保护。要显示它您需要在浏览器中启用JavaScript。

1 Shamir Medical Center, Be’er Ya’akov, Israel

2 PolyPid Ltd, Petach Tikvah, Israel

3 Rabin Medical Center, Beilinson Campus, Petach Tikva,

Israel

4 Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel

5 Sheba Medical Center, Tel-Hashomer, Ramat Gan, Israel

Abstract

Background Despite significant advances in infection control guidelines and practices, surgical site infections (SSIs) remain a substantial cause of morbidity, prolonged hospitalization, and mortality among patients having both elective and emergent surgeries. D-PLEX100 is a novel, antibiotic-eluting polymer–lipid matrix that supplies a high, local concentration of doxycycline for the prevention of superficial and deep SSIs. The aim of our study was to evaluate the safety and efficacy of D-PLEX in addition to standard of care (SOC) in preventing superficial and deep surgical site infections for patients undergoing elective colorectal surgery.

Methods From October 10, 2018 to October 6, 2019, as part of a Phase 2 clinical trial, we randomly assigned 202 patients who had scheduled elective colorectal surgery to receive either standard of care SSI prophylaxis or D-PLEX100 in addition to standard of care. The primary objective was to assess the efficacy of D-PLEX100 in superficial and deep SSI reduction, as measured by the incidence of SSIs within 30 days, as adjudicated by both an individual assessor and a three-person endpoint adjudication committee, all of whom were blinded to study-group assignments. Safety was assessed by the stratification and incidence of treatment-emergent adverse events.

Results One hundred and seventy-nine patients were evaluated in the per protocol population, 88 in the intervention arm [51 males, 37 females, median age (64.0 range: 19–92) years] and 91 in the control arm [57 males, 34 females, median age 64.5 (range: 21–88) years]. The SSI rate within 30 day post-index surgery revealed a 64% relative risk reduction in SSI rate in the D-PLEX100 plus standard of care (SOC) group [n=7/88 (8%)] vs SOC alone [n=20/91 (22%)]; p=0.0115. There was no significant difference in treatment-emergent adverse events.

Conclusions D-PLEX100 application leads to a statistically significant reduction in superficial and deep surgical site infections in this colorectal clinical model without any associated increase in adverse events.

Keywords Surgical site infection · Localized antibiotic therapy · Doxycycline

Pranav Jani1,2  · Umesh Mishra1,2 · Julia Buchmayer3  · Rajesh Maheshwari1,2 · Daphne D’Çruz2  · Karen Walker1,4,5,6,7 · Duygu Gözen8  · Krista Lowe2  · Audrey Wright2  · James Marceau2  · Mihaela Culcer1,2 · Archana Priyadarshi1,2 · Adrienne Kirby9  · James E. Moore10,11 · Ju Lee Oei12,13 · Vibhuti Shah14 · Umesh Vaidya15 · Abdelmoneim Khashana16 · Sunit Godambe17 · Fook Choe Cheah18,19 · Wen‑Hao Zhou20 · Xiao‑Jing Hu21 · Muneerah Satardien22,23

Received: 28 July 2022 / Accepted: 19 September 2022 / Published online: 13 November 2022 © The Author(s) 2022

Abstract

Background Globally, are skincare practices and skin injuries in extremely preterm infants comparable? This study describes skin injuries, variation in skincare practices and investigates any association between them.

Methods A web-based survey was conducted between February 2019 and August 2021. Quantifying skin injuries and describing skincare practices in extremely preterm infants were the main outcomes. The association between skin injuries and skincare practices was established using binary multivariable logistic regression adjusted for regions.

Results Responses from 848 neonatal intensive care units, representing all geographic regions and income status groups were received. Diaper dermatitis (331/840, 39%) and medical adhesive-related skin injuries (319/838, 38%) were the most common injuries. Following a local skincare guideline reduced skin injuries [medical adhesive-related injuries: adjusted odds ratios (aOR)=0.63, 95% confidence interval (CI)=0.45–0.88; perineal injuries: aOR=0.66, 95% CI=0.45–0.96; local skin infections: OR=0.41, 95% CI=0.26–0.65; chemical burns: OR=0.46, 95% CI=0.26–0.83; thermal burns: OR=0.51, 95% CI=0.27–0.96]. Performing skin assessments at least every four hours reduced skin injuries (abrasion: aOR=0.48, 95% CI=0.33–0.67; pressure: aOR=0.51, 95% CI=0.34–0.78; diaper dermatitis: aOR=0.71, 95% CI=0.51–0.99; perineal: aOR=0.52, 95% CI=0.36–0.75). Regional and resource settings-based variations in skin injuries and skincare practices were observed.

Conclusions Skin injuries were common in extremely preterm infants. Consistency in practice and improved surveillance appears to reduce the occurrence of these injuries. Better evidence regarding optimal practices is needed to reduce skin injuries and minimize practice variations.

Keywords Extremely premature infants · Injuries · Neonatal intensive care unit · Skin care · Wounds

Pranav Jani

该Email地址已收到反垃圾邮件插件保护。要显示它您需要在浏览器中启用JavaScript。

Extended author information available on the last page of the article

Mireille Dekker1*, Irene P. Jongerden2 , Martine G. Caris1 , Martine C. de Bruijne2 , Christina M. J. E. Vandenbroucke‑Grauls1,3 and Rosa van Mansfeld1

*Correspondence:

Mireille Dekker

该Email地址已收到反垃圾邮件插件保护。要显示它您需要在浏览器中启用JavaScript。

1 Department of Medical Microbiology and Infection Prevention, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV Amsterdam, The Netherlands

2 Department of Public and Occupational Health, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands

3 Department of Clinical Medicine – Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark

© The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativeco mmons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Abstract

Background Important elements of programs that train and support infection control link nurses (ICLN) are the engagement of stakeholders, support from hospital and ward management and a structure for iterative improvement. The effects of programs, that combine all these elements, are unknown. We evaluated such a comprehensive program to explore its impact on link nurses and infection prevention practices and routines.

Methods We used the RE-AIM framework, a robust, evidence-based framework within the field of Implementation Science, to evaluate the impact of our ICLN training and support program. We used a mixed methods approach and organized the outcomes along its five dimensions: Reach, Effectiveness, Adoption, Implementation and Maintenance.

Results Between 2014 and 2018, on average 91% of the inpatient wards and 58% of the outpatient clinics participated in the program (Reach) and impacted guideline adherence in inpatient wards. Link nurses felt engaged and empowered, and perceived their contribution to these results as pivotal. Ward managers confirmed the value of ICLN to help with implementing IPC practices (Effectiveness). The program was adopted both at the hospital and at the ward level (Adoption). Based on ongoing evaluations, the program was adapted by refining education, training and support strategies with emphasis on ward specific aspects (Implementation). The ICLN program was described as a key component of the infection prevention policy to sustain its effects (Maintenance).

Conclusions Our infection control link nurse program helped ICLN to improve infection prevention practices, especially in inpatient wards. The key to these improvements lay within the adaptability of our link nurse program. The adjustments to the program led to a shift of focus from hospital goals to goals tailored to the ward level. It allowed us to tailor activities to align them with the needs specific to each ward.

Keywords Quality improvement, Patient safety, Nursing practice, Nosocomial infections, Infection prevention