Desinfectie huid en slijmvliezen Module 1.4 Evidence-tabel

Muhd Helmi, 2023

SR and meta-analysis of RCTs (Cochrane review)

Literature search up to 22 April 2022

A: Garland, 2009

B: Kieran, 2018

C: Clarke, 2019

Study design: RCT

Setting:

Hospital

Country:

A: USA

B: Ireland

C: United Kingdom

Source of funding and conflicts of interest:

A: Funded by Grant Number UL1-RR-024134 from the National Center for Research Resources. The trial was funded by Enturia (formerly Medi-Flex). The sponsor reviewed the trial design developed

by the primary investigator. It was not involved with the data collection, implementation, analysis, or

interpretation of data.

B: National Children’s Research Centre (NCRC), Dublin, Ireland. No information available on conflicts of interest

C: Funded by Government fund - National Institute for Health Research, UK. No conflicts of interests reported.

Inclusion criteria SR: (Cluster) RCTs performed in neonatal intensive care unit (NICU), comparing any antiseptic agent (single or in combination) against different concentrations of the same antiseptic agent, or against any another type of antiseptic agent, no antiseptic agent or placebo prior to central catheter placement

Exclusion criteria SR: Cross-over trials and quasi-RCTs

Three studies included

Important patient characteristics at baseline:

N of patients

A: 48

B: 304

C: 114

Gestational age (in weeks) in both intervention (I) and control group (C)

A: mean (SD): I=32.4 (2.9), C=33.0 (4.1)

B: mean (SD): I=27 (2), C=27 (2)

C: median (IQR): I=28 (26 to 30), C=28 (26 to 30)

Body weight (in grams) in both I and C group

A: mean (SD): I=2085 (846), C=1929 (789)

B: mean (SD): I= 1017 (289), C=1014 (326)

C: mean (SD): I=1089.0 (340.5), C=1074.5 (366.3)

Groups comparable at baseline?

Intervention and control group within the studies were comparable at baseline. Between the studies, differences regarding inclusion criteria (gestational age and bodyweight), and different antiseptic measures for catheter care

Describe intervention:

A: 2% chlorhexidine in 70% isopropyl alcohol (2% CHG in 70% IPA)

B: 2% CHG in 70% IPA

C: 2% CHG in 70% IPA

Describe control:

A: 10% povidone-iodine (10% PI)

B: 10% PI

C: 2% chlorhexidine in aqueous solution (2% CHG-A)

End-point of follow-up:

A: No information available

B: From insertion of catheter until patient discharge

C: From insertion of catheter until 48 hours of catheter removal or patient discharge

For how many participants were no complete outcome data available?

(intervention/control)

A: I and C=0 regarding all outcomes

B: I and C=0 regarding all outcomes

C: I= 9.2% (n=8)/ C=0% regarding infection related outcomes; I and C=0 regarding outcome chemical burns

Effect measures: RR [95% CI]

Catheter-related bloodstream infection (CRBSI)

-2% CHG in 70% IPA versus 10% PI

A: not estimable (0 events)

B: 1.32 [0.53, 3.25]

-2% CHG in 70% IPA versus 2% CHG-A

C: 0.80 [0.34, 1.87]

Central line-associated bloodstream infection (CLABSI)

-2% CHG in 70% IPA versus 10% PI

A: 1.00 [0.07, 15.08]

-2% CHG in 70% IPA versus 2% CHG-A

C: 1.14 [0.34, 3.84]

Chemical burns

-2% CHG in 70% IPA versus 10% PI

A: 0.33 [0.01, 7.80]

B: 1.58 [0.27, 9.33]

Pooled effect (fixed effects model):

1.04 [95% CI 0.24 to 4.48] favoring 10% PI

Heterogeneity (I²): 0%

-2% CHG in 70% IPA versus 2% CHG-A

C: 0.98 [0.47, 2.03]

Risk of bias (high, some concerns or low):

Tool used by authors: Cochrane risk of bias

A: High

B: High

C: High