Clinical trial NCT03700749: FALCON Trial Testing Measures to Reduce Surgical Site Infection
Official title: Pragmatic Multicentre FActorial Randomised Controlled triaL Testing Measures to reduCe Surgical Site Infection in lOw and Middle Income couNtries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Abdominal Surgery
Surgical Site Infection
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: Lagos State University
name: Universidad Francisco Marroquín
name: Kigali University Teaching Hospital
name: Christian Medical College and Hospital, Ludhiana, India
name: University of Edinburgh
name: University of the Philippines
name: King Edward Medical University
name: University of Witwatersrand, South Africa
name: Universidad Peruana Cayetano Heredia
name: Centre National Hospitalier Universitaire
name: Ndola Teaching Hospital
name: Hospital Espanol de Veracruz
name: Ministry of Health, Ghana
First posted: 2018-10-09
Enrollment: 5480
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: FALCON 2x2 factorial trial with strata: (1) clean-contaminated and (2) contaminated/dirty. Eligible patients will be randomised at the level of the individual in a 1:1:1:1 ratio between:

A. 2% alcoholic chlorhexidine and non-coated suture B. 2% alcoholic chlorhexidine and triclosan-coated suture C. 10% aqueous povidone-iodine and non-coated suture D. 10% aqueous povidone-iodine and triclosan-coated suture
Primary purpose: TREATMENT

Brief summary: FALCON is a Pragmatic multi-centre trial testing measures to reduce superficial or deep skin infection following abdominal surgery in low and middle income countries. The trial will recruit patients undergoing abdominal surgery. Recruited participants will be randomly assigned to four arms to receive different combinations of skin preparation and sutures for would closure:

A. In this arm surgeon will use 2% alcoholic chlorhexidine for skin cleansing and non-coated suture for wound closure; B. In this arm surgeon will use 2% alcoholic chlorhexidine for skin cleansing and triclosan coated suture for wound closure; C. In this arm surgeon will use for operation 10% aqueous povidone-iodine for skin cleansing and non-coated suture for wound closure; D. In this arm surgeon will use 10% aqueous povidone-iodine for skin cleansing and triclosan-coated suture.

Detailed description: FALCON is a pragmatic, blinded (patient and outcome assessor), 2x2 factorial, stratified, multi-centre randomised controlled trial, with an internal pilot, to evaluate measures to reduce Surgical Site Infection (SSI) rates in patients undergoing surgery with an abdominal incision.

Surgical site infection (SSI) represents a major burden for patients, doctors, and health systems across all settings. SSI is the commonest postoperative complication worldwide and the commonest healthcare-associated infection in low and middle income countries (LMICs). SSIs cause pain, discomfort, disability, and increase the time taken to return to work (3). SSIs increase healthcare costs in all health settings. Whilst there is no direct data on the costs of SSI in LMICs, within the UK National Health Service, SSIs cost approximately £3500 per patient and £700 million per year in total. The impact of increased healthcare costs on patients, communities, and providers can be major in LMICs where personal income is low and patients may be required to pay for their own treatment. SSI has also been associated with one-third of postoperative deaths and accounts for 8% of all deaths caused by a hospital acquired infection.

Strata in FALCON trial are defined according to the anticipated category of wound contamination: (1) clean-contaminated and (2) contaminated/dirty. Eligible patients will be randomised at the level of the individual in a 1:1:1:1 ratio between:

A. 2% alcoholic chlorhexidine and non-coated suture B. 2% alcoholic chlorhexidine and triclosan-coated suture C. 10% aqueous povidone-iodine and non-coated suture D. 10% aqueous povidone-iodine and triclosan-coated suture.

Participant will be recruited from hospitals in Low and Middle Income Countries (LMICs). Participants who is undergoing abdominal surgery with an anticipated clean-contaminated, contaminated or dirty surgical wound will be selected to enter the trial.

The 6 month internal pilot will assess the feasibility of recruitment, compliance with treatment allocation and patient retention and follow-up rates. The main RCT will recruit 5480 participants.

Eligibility criteria: Inclusion Criteria:

* Patients with at least one abdominal incision that is ≥5cm (open or laparoscopic extraction site), with an anticipated clean-contaminated, contaminated or dirty surgical wound.
* Patients undergoing emergency (surgery on an unplanned admission) or elective (surgery on a planned admission) operations.
* Any operative indication, including trauma surgery.
* Patient able and willing to provide written informed consent (signature or a fingerprint).
* Paediatric and adult patients. This criteria is made country-specific. Each country decides the lower age limit for the trial. This is dependent on country-specific regulatory approvals. Age eligibility will vary by country.

Exclusion Criteria:

* Patients with a documented or suspected allergy to iodine, shellfish, or chlorhexidine skin preparation solution.
* Patient unable to complete post-operative follow-up (i.e. will not be contactable after discharge).

Primary outcomes:
measure: Surgical site infection (SSI)
timeFrame: At 30-days post-surgery
Secondary outcomes:
measure: Physiological parameter - SSI at discharge from hospital
timeFrame: Within 30-days post surgery from index operation
measure: Mortality - patient mortality status
timeFrame: Within 30-days post surgery from index operation
measure: Physiological parameter - Unplanned wound opening
timeFrame: Within 30-days post surgery from index operation
measure: Re-operation for SSI
timeFrame: Within 30-days post surgery from index operation
measure: Length of hospital stay for index admission
timeFrame: Within 30-days post surgery from index operation
measure: Participant's Readmission
timeFrame: Within 30-days post surgery from index operation
measure: Questionnaire - return to normal activities
timeFrame: Within 30-days post surgery from index operation
measure: Resistance of organisms
timeFrame: Within 30-days post surgery from index operation
measure: Questionnaire - Health resource usage
timeFrame: Within 30-days post surgery. Health resource usage will only be collected for adult patients (aged 18 and above) at pre-selected centres. This will include costs of post-operative visits to various healthcare professionals.
Other outcomes:
Locations:
city: Lagos
country: Nigeria
facility: Lagos University Teaching Hospital
Study officials:
affiliation: University of Birmingham
name: Dion Morton
role: PRINCIPAL_INVESTIGATOR
References:
citation: NIHR Global Research Health Unit on Global Surgery. Routine sterile glove and instrument change at the time of abdominal wound closure to prevent surgical site infection (ChEETAh): a pragmatic, cluster-randomised trial in seven low-income and middle-income countries. Lancet. 2022 Nov 19;400(10365):1767-1776. doi: 10.1016/S0140-6736(22)01884-0. Epub 2022 Oct 31.
citation: NIHR Global Research Health Unit on Global Surgery. Reducing surgical site infections in low-income and middle-income countries (FALCON): a pragmatic, multicentre, stratified, randomised controlled trial. Lancet. 2021 Nov 6;398(10312):1687-1699. doi: 10.1016/S0140-6736(21)01548-8. Epub 2021 Oct 25.