Condition category
Injury, Occupational Diseases, Poisoning
Date applied
01/07/2009
Date assigned
14/10/2009
Last edited
02/08/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.rossini.bham.ac.uk

Contact information

Type

Scientific

Primary contact

Mr Thomas Pinkney

ORCID ID

Contact details

University Hospital Birmingham
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom

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

http://www.uhb.nhs.uk

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

  1. 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.

  2. 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.

Additional files

Editorial Notes