Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Reduction Of Surgical Site Infection using a Novel Intervention: a randomised controlled trial
Acronym
ROSSINI
Study hypothesis
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
Added 15/03/2010: North Staffordshire Research Ethics Committee approved (ref: 09/H1204/91)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
22/02/2010
Overall trial end date
31/03/2012
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
769 (Amended on 09/05/2012: Recruitment completed, in analysis phase)
Participant exclusion criteria
1. Patients less than 18 years of age, or unable to give informed consent
2. Laparoscopic-assisted cases
Recruitment start date
22/02/2010
Recruitment end date
31/03/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital Birmingham,
Birmingham
B15 2TH
United Kingdom
Sponsor information
Organisation
University Hospitals Birmingham NHS Foundation Trust (UK)
Sponsor details
c/o Dr Christopher Counsell
Birmingham Clinical Research Office
HSRC Building
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) funding pending
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
1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21970469
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23903454
Publication citations
-
Protocol
Pinkney TD, Bartlett DC, Hawkins W, Mak T, Youssef H, Futaba K, Harrison G, Gheorghe A, Bradbury JM, Calvert MJ, Dowswell G, Magill L, Redman V, Wilson S, Leaper D, Morton DG, , Reduction of surgical site infection using a novel intervention (ROSSINI): study protocol for a randomised controlled trial., Trials, 2011, 12, 217, doi: 10.1186/1745-6215-12-217.
-
Results
Pinkney TD, Calvert M, Bartlett DC, Gheorghe A, Redman V, Dowswell G, Hawkins W, Mak T, Youssef H, Richardson C, Hornby S, Magill L, Haslop R, Wilson S, Morton D, , , Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial)., BMJ, 2013, 347, f4305.