A Phase 3 interventional study of 2% chlorhexidine + non-coated suture and 2% chlorhexidine + coated suture in Abdominal Surgery and Surgical Site Infection, sponsored by University of Birmingham. Status unknown at 1 site in Nigeria. Open to participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2019-09-26.
Sponsored by University of Birmingham · Phase 3, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 5,480 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →University of Birmingham is the lead sponsor of 179 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2%alcoholic chlorhexidine + non-coated suture. Intervention: skin preparation with 2%alcoholic chlorhexidine in combination with non-coated suture for abdominal fascial closure.
Drug: 2% chlorhexidine + non-coated suture
2%alcoholic chlorhexidine + triclosan-coated suture. Intervention: skin preparation with 2%alcoholic chlorhexidine in combination with triclosan-coated suture for abdominal fascia closure.
Drug: 2% chlorhexidine + coated suture
10% povidone-iodine and non-coated suture. Intervention: skin preparation with 10% povidone-iodine in combination with non-coated suture for abdominal fascial closure.
Drug: 10%povidone-iodine + non-coated suture
10%povidone-iodine/triclosan-coated suture. Intervention: skin preparation with 10% povidone-iodine in combination with triclosan-coated suture for abdominal fascial closure.
Drug: 10%povidone-iodine + coated suture
Interventions: 2% alcoholic chlorhexidine non-coated suture
Interventions: 2% alcoholic chlorhexidine triclosan coated suture
Interventions: 10% povidone-iodine non-coated suture non-coated suture
Interventions: 10% povidone-iodine triclosan coated suture
Surgical site infection (SSI)
Deep incisional or superficial incisional SSI which must occur within 30 days of the index operation. The infection must involve the skin, subcutaneous, muscular or fascial layers of the incision. Patient must at least have one of the following: (1) purulent discharge from wound; (2) organisms detected from wound swab; (3) Wound opened spontaneously or by a clinician AND, at the surgical wound, the patient has at least one of: pain or tenderness; localised swelling; redness; heat; systemic fever (\>38°C); (4) Diagnosis of SSI by a clinician or on imaging.
Time frame: At 30-days post-surgery
Physiological parameter - SSI at discharge from hospital
Deep incisional or superficial incisional SSI. The infection must involve the skin, subcutaneous, muscular or fascial layers of the incision and the patient must have one of the following: (1) purulent discharge from wound; (2) organisms detected from wound swab; (3) Wound opened spontaneously or by a clinician AND, at the surgical wound, the patient has at least one of: pain or tenderness; localised swelling; redness; heat; systemic fever (\>38°C); (4) Diagnosis of SSI by a clinician or on imaging.
Time frame: Within 30-days post surgery from index operation
Mortality - patient mortality status
Mortality within 30-days post surgery
Time frame: Within 30-days post surgery from index operation
Physiological parameter - Unplanned wound opening
Whether an unplanned wound opening has occurred at abdominal surgical site within 30-days post surgery, spontaneously opened or by clinician
Time frame: Within 30-days post surgery from index operation
Re-operation for SSI
Re-operation for SSI within 30-days post surgery
Time frame: Within 30-days post surgery from index operation
Length of hospital stay for index admission
Length of hospital stay for index admission will be collected and will measure time from surgery to time of discharge.
Time frame: Within 30-days post surgery from index operation
Participant's Readmission
Whether patient readmitted within 30-days post surgery
Time frame: Within 30-days post surgery from index operation
Questionnaire - return to normal activities
Return to normal activities (e.g. work, school, or family duties) ascertained by trial specific questionnaire
Time frame: Within 30-days post surgery from index operation
Resistance of organisms
Resistance of organisms detected from wound swabs to prophylactic antibiotics administered within 1 hour of incision
Time frame: Within 30-days post surgery from index operation
Questionnaire - Health resource usage
Health resource usage within 30-days post surgery ascertained by trial specific questionnaire
Time frame: 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.
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Birmingham