Reduction Of Surgical Site Infection using a Novel Intervention
| ISRCTN | ISRCTN40402832 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40402832 |
| Secondary identifying numbers | 1 |
- Submission date
- 01/07/2009
- Registration date
- 14/10/2009
- Last edited
- 02/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Thomas Pinkney
Scientific
Scientific
University Hospital Birmingham
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Reduction Of Surgical Site Infection using a Novel Intervention: a randomised controlled trial |
| Study acronym | ROSSINI |
| Study objectives | The aim of the ROSSINI trial is to investigate whether the use of a wound-edge protection device in adult patients undergoing abdominal surgery experience a lower rate of surgical site infection (SSI) than those cases not utilising the device. As of 15/03/2010 this record was updated to include a change the the anticipated start date of this trial; the initial anticipated start date was 01/09/2009. As of 09/05/2012, the anticipated end date of this trial has been updated from 31/08/2014 to 31/03/2012. Target number of participants for the trial has been updated from 750 to 769. |
| Ethics approval(s) | Added 15/03/2010: North Staffordshire Research Ethics Committee approved (ref: 09/H1204/91) |
| Health condition(s) or problem(s) studied | Wound infection |
| Intervention | The intervention is the use of a 'wound edge protector', a device which is placed in the wound during surgery and aims to reduce contamination of the wound edges and therefore reduce post-operative wound infection. The device is removed at the end of the procedure. Patients will be randomised to 2 arms - wound protector or no wound protector. Other aspects of their treatment/surgery will remain unchanged. Follow up will consist of blinded wound review at day 5 - 7 (prior to discharge) and again in outpatients at around 30 days. A patient questionnaire covering the intervening time period will also be completed. |
| Intervention type | Other |
| Primary outcome measure | Incidence of post-operative wound infection, assessed at 7 and 30 days |
| Secondary outcome measures | Assessed at 30 days: 1. Health related quality of life 2. Length of hospital stay 3. Cost effectiveness 4. The effect on the efficacy of a wound edge protection device in reducing wound infection of: 4.1. Degee of abdominal contamination 4.2. Comorbidity 4.3. Duration of surgery 4.4. Grade of surgeon closing the wound |
| Overall study start date | 22/02/2010 |
| Completion date | 31/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 769 (Amended on 09/05/2012: Recruitment completed, in analysis phase) |
| Key inclusion criteria | All adults (greater than 18 years of age, either sex) undergoing laparotomy via a midline incision (for any surgical indication), including both elective and emergency operations. |
| Key exclusion criteria | 1. Patients less than 18 years of age, or unable to give informed consent 2. Laparoscopic-assisted cases |
| Date of first enrolment | 22/02/2010 |
| Date of final enrolment | 31/03/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Hospital Birmingham,
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Sponsor information
University Hospitals Birmingham NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Christopher Counsell
Birmingham Clinical Research Office
HSRC Building
University of Birmingham
Birmingham
B15 2TT
England
United Kingdom
| Website | http://www.uhb.nhs.uk |
|---|---|
"ROR" |
https://ror.org/014ja3n03 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) funding pending
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 04/10/2011 | Yes | No | |
| Results article | results | 31/07/2013 | Yes | No |
