Dr Nathalie van der Mee-Marquet
Laboratoire de Microbiologie et Hygiène
+33 (0)2 34 38 94 30
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 not required according to the Ethical Committee of the Medical Regional Center, dated 17/12/2003
A prospective, multicentre, randomised equivalence study
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Catheter-related septic thrombophlebitis
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.
Primary outcome measure
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
Overall trial end date
Reason abandoned (if study stopped)
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
Target number of participants
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
Recruitment end date
Countries of recruitment
Trial participating centre
West Scientific Coordination Center for the Fight against Nosocomial Infections (CCLIN) (France)
2 Rue de l'Hôtel-Dieu
+33 (0)2 99 87 35 30
West Scientific Coordination Center for the Fight against Nosocomial Infections (Centre de Coordination de Lutte Contre les Infections Nosocomiales Ouest [CCLIN]) (France)
Funding Body Type
Funding Body Subtype
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
Basic results (scientific)