Effect of an information leaflet about surgical wound infection (SWI) on recollection of information and satisfaction of patients operated on for scheduled surgery

ISRCTN	ISRCTN58419709
DOI	https://doi.org/10.1186/ISRCTN58419709
Secondary identifying numbers	N/A

Submission date: 12/04/2008
Registration date: 30/07/2008
Last edited: 30/07/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Véronique Merle
Scientific

Department of Epidemiology and Public Health
Rouen University Hospital
Rouen
76031
France

Email	veronique.merle@chu-rouen.fr

Study information

Study design	Single-centre, randomised, single-blind trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	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(s)	Ethics approval was not required as this study involved only usual processes of care; neither invasive procedures nor medical interventions were involved.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	30/09/2005
Completion date	01/04/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	200
Key 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
Key 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
Date of first enrolment	30/09/2005
Date of final enrolment	01/04/2007

Locations

Countries of recruitment

France

Study participating centre

Department of Epidemiology and Public Health

Rouen
76031
France

Sponsor information

Rouen University Hospital (France)
University/education

1 Rue de Germont
Rouen
76031
France

Email	secretariat.DRC@chu-rouen.fr
Website	http://www.chu-rouen.fr
"ROR"	https://ror.org/04cdk4t75

Funders

Funder type

University/education

Rouen University Hospital (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