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FALCON Trial Testing Measures to Reduce Surgical Site Infection (FALCON)

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ClinicalTrials.gov Identifier: NCT03700749
Recruitment Status : Not yet recruiting
First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Collaborators:
Lagos State University
Universidad Francisco Marroquín
Kigali University Teaching Hospital
Christian Medical College and Hospital, Ludhiana, India
University of Edinburgh
University of the Philippines
King Edward Medical University
University of Witwatersrand, South Africa
Universidad Peruana Cayetano Heredia
Centre National Hospitalier Universitaire
Ndola Teaching Hospital
Hospital Espanol de Veracruz
Tamale Teaching Hospital, Tamale
Information provided by (Responsible Party):
University of Birmingham

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.


Condition or disease Intervention/treatment Phase
Abdominal Surgery Surgical Site Infection Drug: 2% chlorhexidine + non-coated suture Drug: 2% chlorhexidine + coated suture Drug: 10%povidone-iodine + non-coated suture Drug: 10%povidone-iodine + coated suture Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5480 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
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

Masking: Double (Participant, Outcomes Assessor)
Masking Description: Patients and outcome assessors will be blinded. The operating surgeon will not perform outcome assessment.
Primary Purpose: Treatment
Official Title: Pragmatic Multicentre FActorial Randomised Controlled triaL Testing Measures to reduCe Surgical Site Infection in lOw and Middle Income couNtries
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Povidone

Arm Intervention/treatment
Active Comparator: 2%chlorhexidine + non-coated suture
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

Interventions:

2% alcoholic chlorhexidine non-coated suture


Active Comparator: 2%chlorhexidine + 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

Interventions:

2% alcoholic chlorhexidine triclosan coated suture


Active Comparator: 10% povidone-iodine + non-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

Interventions:

10% povidone-iodine non-coated suture non-coated suture


Active Comparator: 10%povidone-iodine + 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:

10% povidone-iodine triclosan coated suture





Primary Outcome Measures :
  1. Surgical site infection (SSI) [ Time Frame: At 30-days post-surgery ]
    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.


Secondary Outcome Measures :
  1. Physiological parameter - SSI at discharge from hospital [ Time Frame: Within 30-days post surgery from index operation ]
    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.

  2. Mortality - patient mortality status [ Time Frame: Within 30-days post surgery from index operation ]
    Mortality within 30-days post surgery

  3. Physiological parameter - Unplanned wound opening [ Time Frame: Within 30-days post surgery from index operation ]
    Whether an unplanned wound opening has occurred at abdominal surgical site within 30-days post surgery, spontaneously opened or by clinician

  4. Re-operation for SSI [ Time Frame: Within 30-days post surgery from index operation ]
    Re-operation for SSI within 30-days post surgery

  5. Length of hospital stay for index admission [ Time Frame: Within 30-days post surgery from index operation ]
    Length of hospital stay for index admission will be collected and will measure time from surgery to time of discharge.

  6. Participant's Readmission [ Time Frame: Within 30-days post surgery from index operation ]
    Whether patient readmitted within 30-days post surgery

  7. Questionnaire - return to normal activities [ Time Frame: Within 30-days post surgery from index operation ]
    Return to normal activities (e.g. work, school, or family duties) ascertained by trial specific questionnaire

  8. Resistance of organisms [ Time Frame: Within 30-days post surgery from index operation ]
    Resistance of organisms detected from wound swabs to prophylactic antibiotics administered within 1 hour of incision

  9. Questionnaire - Health resource usage [ 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. ]
    Health resource usage within 30-days post surgery ascertained by trial specific questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700749


Contacts
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Contact: Tina Griffin, BMedSc 0121 414 4762 falcon@trials.bham.ac.uk
Contact: Rachel Lillywhite, BA 0121 414 4762 GlobalSurg@trials.bham.ac.uk

Sponsors and Collaborators
University of Birmingham
Lagos State University
Universidad Francisco Marroquín
Kigali University Teaching Hospital
Christian Medical College and Hospital, Ludhiana, India
University of Edinburgh
University of the Philippines
King Edward Medical University
University of Witwatersrand, South Africa
Universidad Peruana Cayetano Heredia
Centre National Hospitalier Universitaire
Ndola Teaching Hospital
Hospital Espanol de Veracruz
Tamale Teaching Hospital, Tamale
Investigators
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Principal Investigator: Dion Morton University of Birmingham

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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT03700749     History of Changes
Other Study ID Numbers: RG_17-126
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Iodine
Cadexomer iodine
Povidone-Iodine
Triclosan
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents