Contact information
Type
Scientific
Primary contact
Dr Véronique Merle
ORCID ID
Contact details
Department of Epidemiology and Public Health
Rouen University Hospital
Rouen
76031
France
veronique.merle@chu-rouen.fr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Supplying patients who are scheduled to be operated on with a leaflet about surgical wound infection (SWI) could influence recollection of information, satisfaction regarding information and patient's opinion regarding SWI.
Ethics approval
Ethics approval was not required as this study involved only usual processes of care; neither invasive procedures nor medical interventions were involved.
Study design
Single-centre, randomised, single-blind trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Surgical wound infection
Intervention
According to the French regulation, no formal approval was required from the patient. To avoid memorisation bias, patients were told that the subject of the study was quality of care, and not information. They were asked if they agreed to be interviewed by phone 5 weeks after surgery about quality of their care.
Intervention group: Patients received oral information about surgical wound infection from the surgeon plus an information leaflet.
Control group: Patients received only oral information about surgical wound infection from the surgeon.
Both oral information and the leaflet were given to the patients before surgery, during an outpatient visit with the surgeon.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Patients' satisfaction concerning information about surgical wound infection, assessed by a telephone interview 5 +/- 1 week after surgery.
Secondary outcome measures
The following were assessed by a telephone interview 5 +/- 1 week after surgery:
1. Recollection of information
2. Attitude towards surgery and surgical wound infection
Overall trial start date
30/09/2005
Overall trial end date
01/04/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged over 18 years, both males and females
2. Patients scheduled for surgery in the Digestive Surgery Department of the Rouen University Hospital
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Patients younger than 18 years
2. Patients requiring an emergency surgery
3. Patients with literacy difficulties or with cognitive impairment
4. Patients who do not speak French
5. Patients refusing to be interviewed 5 weeks after surgery
Recruitment start date
30/09/2005
Recruitment end date
01/04/2007
Locations
Countries of recruitment
France
Trial participating centre
Department of Epidemiology and Public Health
Rouen
76031
France
Sponsor information
Organisation
Rouen University Hospital (France)
Sponsor details
1 Rue de Germont
Rouen
76031
France
secretariat.DRC@chu-rouen.fr
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Rouen University Hospital (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