Condition category
Circulatory System
Date applied
22/05/2006
Date assigned
19/06/2006
Last edited
20/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nathalie van der Mee-Marquet

ORCID ID

Contact details

CHU Tours
Hôpital Trousseau
Laboratoire de Microbiologie et Hygiène
Tours
37044
France
+33 (0)2 34 38 94 30
n.vandermee@chu-tours.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Thrombophlebitis is an early sign, preceding infection, frequently associated with infectious complications of the use of Peripheral Venous Catheters (PVCs). It occurs more than 24 hours after insertion, in 12 to 34% of cases and more than 48 hours after insertion, in 36 to 65% of cases. The observation of local complications associated with PVCs, and the comparison of their frequency as a function of certain criteria (nature of the catheter, antiseptic used, insertion site etc.) have previously been used to study the risk factors for PVC-linked infections. In 1983, Maddox et al. conducted a prospective double-blind study with 195 men to evaluate the effect of inline intravenous filters on post infusion phlebitis and bacterial colonization of catheters. Gabel et al. conducted a comparative study of a new skin preparation method for peripheral intravenous lines and studied in 60 patients the incidence of PVC infection in relation to skin preparation methods. The insertion sites were then evaluated for multiple signs including redness, inflammation, pain or tenderness. In 1989, Jacquot et al. conducted a study which compared peripheral intravenous Teflon® and Vialon® catheters. The incidence of phlebitis was then assessed on 170 PVCs.

Strict compliance with skin preparation procedures before insertion of the catheter is one of the principal means of preventing PVC-linked infection. Nevertheless, the procedures for the insertion and care of a PVC are poorly adhered to in routine practice. This lack of compliance may be attributed to the time-consuming nature of the recommended procedure. With the intention of encouraging compliance with the recommendations, we have developed a simplified, effective method for skin preparation for the insertion of PVCs, involving two successive swabbings with alcoholic antiseptic imbibed compresses.

Based on these data, we therefore carried out a randomised equivalence study comparing the frequency of signs of thrombophlebitis at the site of insertion for the two procedures, the two-step procedure and the standard four-step procedure.

Ethics approval

Ethics approval not required according to the Ethical Committee of the Medical Regional Center, dated 17/12/2003

Study design

A prospective, multicentre, randomised equivalence study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

Condition

Catheter-related septic thrombophlebitis

Intervention

With the intention of encouraging compliance with the recommendations, we have developed a simplified, effective method for skin preparation for the insertion of PVCs, involving two successive swabbings with alcoholic antiseptic imbibed compresses.

There will be two procedures tested in this trial:
1. The two-step procedure
2. The standard four-step procedure

PVCs were inserted and maintained by nursing staff. The investigators were responsible for checking that the prescribed skin preparation protocol was adhered to and for collecting data concerning possible confounding factors. These included the age of the patient, immunosuppression, nature of the catheter, number of manipulations per day, duration of catheterisation and the nature of the perfused solutes.

Inspection of the insertion site is a key part of nursing care. The patients were monitored daily throughout the time of perfusion, until withdrawal of the catheter, for a maximum of 72 hours.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The appearance of precursor signs of infection at the insertion site, as evaluated according to the Maddox scale. The nurses were trained in the use of this scale before the start of the study.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/05/2004

Overall trial end date

01/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Hospitalised, consenting adults aged over 18 years
2. Male or female
3. Requiring the insertion of a continuous PVC with a treatment duration of more than 48 hours
4. Those for whom either skin preparation procedure could be used

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

248 subjects

Participant exclusion criteria

1. The insertion of a catheter for emergency perfusion
2. Allergy to povidone
3. A planned intravenous treatment time of less than 48 hours
4. The presence of skin lesions at the chosen insertion site
5. Being in the last three months of pregnancy
6. Refusal to give consent
7. Patient unconscious or incapable of understanding the information given

Recruitment start date

01/05/2004

Recruitment end date

01/12/2004

Locations

Countries of recruitment

France

Trial participating centre

CHU Tours
Tours
37044
France

Sponsor information

Organisation

West Scientific Coordination Center for the Fight against Nosocomial Infections (CCLIN) (France)

Sponsor details

CHU Hôtel-Dieu
2 Rue de l'Hôtel-Dieu
CS 26419
Rennes
35064
France
+33 (0)2 99 87 35 30
fcoulomb@ch-dreux.fr

Sponsor type

Hospital/treatment centre

Website

http://www.cclinouest.com

Funders

Funder type

Hospital/treatment centre

Funder name

West Scientific Coordination Center for the Fight against Nosocomial Infections (Centre de Coordination de Lutte Contre les Infections Nosocomiales Ouest [CCLIN]) (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes