The CHEETAH Trial

Surgical site infection (SSI) represents a major burden for patients, doctors and health systems around the world, but is potentially preventable. SSI is the most common postoperative complication across all income and development settings, and the most common healthcare-associated infection in low-and middle-income countries (LMICs). It has been associated with one-third of postoperative deaths and accounts for 8% of all deaths caused by a nosocomial infection. Rates vary significantly between different types of surgery, but it is particularly prevalent in abdominal operations; as many as one in four patients get an SSI when the operation involves the bowel.

Improving surgical outcomes is a global health priority, highlighted by the Lancet Commission on Global Surgery. Recent WHO guidelines made 29 recommendations for intraoperative and postoperative measures to prevent SSI. Despite inclusion of strongly graded recommendations, there was little high-quality evidence in support of most interventions. In addition, none of the evidence used was derived from resource limited settings, leading to uncertainty about implementation of measures in LMICs, in particular. The specific interventions to be tested in this study were selected by a Delphi process from a long list of potential interventions based on the the WHO guidelines.

A key factor influencing SSI rates is intraoperative contamination (opening the gut, genital or urinary tracts). In clean (non-contaminated) surgery, the infection rate is low and benefits from research targeting SSI rates in those patients are limited. CHEETAH will therefore focus on clean-contaminated, contaminated and dirty surgery. A cluster randomised design is considered the most appropriate design to minimise the risk of contamination in the control arm of the trial. Once theatre staff have been trained to implement the intervention (of separating sterile surgical instruments and gloves at the time of wound closure) it is likely to become routine practice, making individual randomisation unfeasible.

To assess whether the practice of using separate sterile gloves and instruments to close wounds at the end of surgery compared to current routine hospital practice can reduce surgical site infection at 30-days post-surgery for patients undergoing clean-contaminated, contaminated or dirty abdominal surgery.

CHEETAH is an international, multicentre, 2-arm, cluster randomised controlled trial, with an internal pilot. Clusters are defined as hospitals, which means hospitals rather than patients are randomised.

Patients (adults and children) undergoing emergency or elective abdominal surgery for a clean-contaminated, contaminated or dirty operation.

The intervention used within CHEETAH is:

Change of gloves and use of separate, sterile instruments before closing the abdominal wall
Comparator (current routine hospital practice):

No change of gloves or use of separate, sterile instruments before closing the abdominal wall

The CHEETAH trial has a 12 month internal pilot of 12 clusters and approximately 600 participants to assess:

• Whether hospitals adhere to their allocation
• What proportion of patients who are eligible for CHEETAH can be followed up successfully at 30 days after their surgery

Countries:

• LMICs defined by the Development Assistance Committee (DAC) Official Development Assistance (ODA) list where there are at least 4 eligible hospitals per country
• At least four eligible hospitals per country

Hospitals (clusters):

• Hospitals where glove and instrument change is not currently routine hospital practice
  Participants:
  a. Emergency (surgery on an unplanned admission) or elective (surgery on a planned admission)
  b. Intraoperative finding of clean-contaminated, contaminated or dirty surgery
  c. With at least one abdominal incision that is ≥5cm

• Patients aged xx years and over on the day of surgery. NB: This criteria must be made country-specific. This will be dependant on country-specific regulatory approvals.

Sponsor

The University of Birmingham (UoB) is the sponsor of the CHEETAH trial in collaborating countries.

International Coordinating Centre

The International Coordinating Centre CHEETAH trial office is at the University of Birmingham Clinical Trials Unit (BCTU).
Each country will appoint a National Coordinating Investigator (NCI) and a National Coordinating Centre (NCC) – the Hub – who will take national responsibility for the study. The Hubs will be responsible for coordinating recruitment from a range of representative local hospitals – spokes.

Central and National Trial Management Group

The Central Trial Management Group (CTMG) includes those individuals responsible for the day-to-day management of the trial. This will include the trial CI, lead methodologists, patient representatives and CHEETAH central trial management staff.

Trial Steering Committee

The Trial Steering Committee provides overall supervision of the trial and ensures that the trial is being conducted in accordance with the principles of Good Clinical Practice and other relevant regulations.

Data Monitoring Committee

The Data Monitoring Committee will give advice on whether the accumulated data from the trial, together with the results from other relevant research, justifies the continuing recruitment of further participants.

Central Trial Management Group (University of Birmingham)

CHEETAH Trial Team

Birmingham Clinical Trials Unit, Public Health Building

University of Birmingham, Edgbaston, B15 2TT

Email: Cheetah@trials.bham.ac.uk

Tel: from UK 0121 415 9103, International +44121 415 9103

Twitter: @cheetahRCT