Intervention to ascertain the most effective disinfection agent, and time to clean intravenous access port in adult patients

Effectiveness of decontamination of Smartsite needleless connectors with 70% Alcohol or 2% chlorhexidine in 70% alcohol timed at 5, 10 or 15 seconds in the clinical environment, a factorial randomized control trial in adult medical patients

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001448134

Enrollment

300

Registered

2019-10-18

Start date

2017-12-01

Completion date

2018-12-21

Last updated

2019-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The time required to successfully disinfect needleless connectors varies between 5 and 60 seconds. The primary aim of this research was to establish the most effective disinfection agent (70% isopropyl alcohol or 2% chlorhexidine in 70% isopropyl alcohol) with decontamination (scrubbing) times of 5, 10 and 15 seconds (6 groups). The needleless connector was swabbed prior to decontamination, then following randomised decontamination. It is anticipated that the shorter the time of effective decontamination of the needleless connector the more likely healthcare workers will comply with the decontamination procedure

Interventions

Factorial study. Needleless connectors were disinfected with 70% isopropyl alcohol, 5 10 and 15 seconds or 2% chlorhexidine in 70% isopropyl alcohol for 5, 10 or 15 seconds. Participants gave verbal consent for their needleless connectors to be swabbed (pre-decontamination of the needleless connector). The needleless connector was then swabbed by the researcher for a specific period of time with a designated antiseptic agent (as per randomisation service). After disinfection of the needleless connector it was again swabbed and the swab sent to the microbiology lab to ascertain any micro-organism growth. A comparison of growth before and after decontamination determined success of the intervention. Needleless connectors were swabbed with either 70% isopropyl alcohol prep pads (for professional and hospital use) - prepackaged, or 70% isopropyl alcohol with 2 % chlorhexidine (also prepacked). Prep pads were sterile. The needleless connectors were manually cleaned by the researcher (after cleaning hands) for 5, 10 or 15 seconds (as per randomisation). Each needleless connector was only used once in the study, and pre and post swab was undertaken for all 300 randomised needleless connectors. The intervention was carried out by a Registered Nurse (part of the research team) Adherence to the protocol (with strict instructions on how to decontaminate the needleless connector) was adhered to by the research nurse, practice was observed by another Registered Nurse (also part of the research) team. Analysis of swabs was undertaken by the Microbiologist. A data collection sheet was completed for each of the 300 needleless connectors. There were six arms to the trial (decontamination). Isopropyl alcohol 70% for 5 seconds, Isopropyl alcohol 70% for 10 seconds, Isopropyl alcohol 70% for 15 seconds, Isopropyl alcohol (70%) with 2% chlorhexidine 5 seconds, Isopropyl alcohol (70%) with 2% chlorhexidine for 10 seconds, and Isopropyl alcohol (70%) with 2% chlorhexidine for 15 seconds

Study design

Allocation

Randomised controlled trial

Intervention model

Factorial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

Peripheral intravenous catheter insitu for >24 hours Peripheral intravenous catheter free on a infusion Patient consent

Exclusion criteria

Inability to consent Allergy to chlorhexidine

Outcome results