Surgical Site Infection Clinical Trial
— FALCONOfficial 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.
Status | Recruiting |
Enrollment | 5480 |
Est. completion date | July 31, 2021 |
Est. primary completion date | July 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 100 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
Nigeria | Lagos University Teaching Hospital | Lagos |
Lead Sponsor | Collaborator |
---|---|
University of Birmingham | Centre National Hospitalier Universitaire, Christian Medical College and Hospital, Ludhiana, India, Hospital Espanol de Veracruz, Kigali University Teaching Hospital, King Edward Medical University, Lagos State University, Ndola Teaching Hospital, Tamale Teaching Hospital, Tamale, Universidad Francisco Marroquín, Universidad Peruana Cayetano Heredia, University of Edinburgh, University of the Philippines, University of Witwatersrand, South Africa |
Nigeria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | At 30-days post-surgery | |
Secondary | 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. | Within 30-days post surgery from index operation | |
Secondary | Mortality - patient mortality status | Mortality within 30-days post surgery | Within 30-days post surgery from index operation | |
Secondary | 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 | Within 30-days post surgery from index operation | |
Secondary | Re-operation for SSI | Re-operation for SSI within 30-days post surgery | Within 30-days post surgery from index operation | |
Secondary | 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. | Within 30-days post surgery from index operation | |
Secondary | Participant's Readmission | Whether patient readmitted within 30-days post surgery | Within 30-days post surgery from index operation | |
Secondary | Questionnaire - return to normal activities | Return to normal activities (e.g. work, school, or family duties) ascertained by trial specific questionnaire | Within 30-days post surgery from index operation | |
Secondary | Resistance of organisms | Resistance of organisms detected from wound swabs to prophylactic antibiotics administered within 1 hour of incision | Within 30-days post surgery from index operation | |
Secondary | Questionnaire - Health resource usage | Health resource usage within 30-days post surgery ascertained by trial specific questionnaire | 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. |
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