Surgical Site Infection Clinical Trial
Official title:
Pragmatic Multicentre FActorial Randomised Controlled triaL Testing Measures to reduCe Surgical Site Infection in lOw and Middle Income couNtries
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.
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.
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