Efficacy and safety of a two-step method of skin preparation for peripheral intravenous catheter insertion - a prospective multicentre randomised trial
| ISRCTN | ISRCTN01075518 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01075518 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/05/2006
- Registration date
- 19/06/2006
- Last edited
- 02/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Nathalie van der Mee-Marquet
Scientific
Scientific
CHU Tours
Hôpital Trousseau
Laboratoire de Microbiologie et Hygiène
Tours
37044
France
| Phone | +33 (0)2 34 38 94 30 |
|---|---|
| n.vandermee@chu-tours.fr |
Study information
| Study design | A prospective, multicentre, randomised equivalence study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Diagnostic |
| Scientific title | Efficacy and safety of a two-step method of skin preparation for peripheral intravenous catheter insertion - a prospective multicentre randomised trial |
| Study objectives | 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(s) | Ethics approval not required according to the Ethical Committee of the Medical Regional Center, dated 17/12/2003 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2004 |
| Completion date | 01/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 248 subjects |
| Total final enrolment | 248 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 01/12/2004 |
Locations
Countries of recruitment
- France
Study participating centre
CHU Tours
Tours
37044
France
37044
France
Sponsor information
West Scientific Coordination Center for the Fight against Nosocomial Infections (CCLIN) (France)
Hospital/treatment centre
Hospital/treatment centre
CHU Hôtel-Dieu
2 Rue de l'Hôtel-Dieu
CS 26419
Rennes
35064
France
| Phone | +33 (0)2 99 87 35 30 |
|---|---|
| fcoulomb@ch-dreux.fr | |
| Website | http://www.cclinouest.com |
Funders
Funder type
Hospital/treatment centre
West Scientific Coordination Center for the Fight against Nosocomial Infections (Centre de Coordination de Lutte Contre les Infections Nosocomiales Ouest [CCLIN]) (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 31/01/2007 | 02/09/2021 | Yes | No |
Editorial Notes
02/09/2021: Publication reference and total final enrolment added.
