Condition category
Infections and Infestations
Date applied
12/04/2008
Date assigned
30/07/2008
Last edited
30/07/2008
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 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

http://www.chu-rouen.fr

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

Publication citations

Additional files

Editorial Notes