Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201907849473370 Date of Registration: 03/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title FALCON Protocol
Official scientific title Pragmatic multicentre FActorial randomised controlled triaL testing measures to reduCe surgical site infection in lOw and middle income couNtries (FALCON)
Brief summary describing the background and objectives of the trial Title: Pragmatic multicentre factorial randomised controlled trial testing measures to reduce surgical site infection in low and middle income countries. Aim: To assess whether either (1) 2% alcoholic chlorhexidine versus 10% povidone-iodine for skin preparation, or (2) triclosan-coated suture versus non-coated suture for fascial closure, can reduce surgical site infection at 30-days post-surgery for each of (1) clean-contaminated and (2) contaminated/dirty surgery. Design: Pragmatic, patient and outcome assessor blinded, 2x2 factorial, stratified, multi-centre randomised controlled trial, with an internal pilot. Strata are defined according to the anticipated category of wound contamination: (1) clean-contaminated and (2) contaminated/dirty. Participants: Patients (adults and children) undergoing surgery with abdominal incision of at least ≥5cm, with an anticipated (1) clean-contaminated. or (2) contaminated or dirty wound. Participants undergoing emergency or elective, and open or laparoscopic surgery are eligible. Interventions: (1) 2% chlorhexidine-alcohol versus 10% povidone-iodine skin preparation (2) triclosan-coated suture versus non-coated suture for fascial closure. Outcomes: The primary outcome is surgical site infection (SSI) 30 days post-surgery, defined according to Centre for Disease Control criteria. Sample size: The strata will be separately powered to detect a clinically important absolute risk reduction of 4% and 6% in the respective strata (90% power, 5% sig level and 15% loss to follow-up). For the clean-contaminated stratum, GlobalSurg-2 (feasibility) data suggests a control group SSI event rate of 12%. A 4% absolute reduction to 8% (i.e. a RR of 0.67) would require 2,780 participants in total. For the contaminated/dirty stratum, GlobalSurg-2 (feasibility) data suggests a control group SSI event rate of 30%. A 6% absolute reduction to 24% (i.e. a RR of 0.80) would require 2,700 participants in total. Combining both strata, a pooled sample size
Type of trial RCT
Acronym (If the trial has an acronym then please provide) FALCON
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 26/08/2019
Actual trial start date 09/09/2019
Anticipated date of last follow up 23/10/2020
Actual Last follow-up date 01/02/2021
Anticipated target sample size (number of participants) 5480
Actual target sample size (number of participants) 5480
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
NCT03700749 ClinicalTrial.gov, uk
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Skin prep and sutures N/A N/A (1) 2% chlorhexidine-alcohol versus 10% povidone-iodine skin preparation (2) triclosan-coated suture versus non-coated suture for fascial closure. 2740 Active-Treatment of Control Group
Experimental Group Skin prep N/A N/A • 2% alcoholic chlorhexidine skin preparation • 10% aqueous povidone-iodine skin preparation • Coated PDS or Vicryl sutures for abdominal fascial closure • Non-coated PDS or Vicryl sutures for abdominal fascial closure 2740
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. Definitions and examples of contamination are given in Table 1. 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). Patients aged 5 years and over. 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). 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 5 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/08/2018 University of Birmingham Science Technology Engineering and Mathematics Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
Edgbaston Birmingham 0044 United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome 1. SSI at discharge from hospital 2. Mortality within 30-days post-surgery 3. Unplanned wound opening within 30-days of surgery 4. Re-operation for SSI within 30-days of surgery 5. Length of hospital stay for index admission 6. Readmission within 30 days of surgery 7. Return to normal activities (e.g. work, school, or family duties) within 30-days 8. Resistance of organisms detected from wound swabs to prophylactic antibiotics administered within 1 hour of incision 9. The following health resource usage outcomes within 30-days will only be collected for adult patients (aged 18 years and above) at pre-selected centres: length of stay in hospital; readmission to hospital; discharge from hospital with (i) pain killers, (ii) antibiotics, (iii) wound dressings; cost of post-operative visit with wound problem (i) to hospital, (ii) to a community doctor, (iii) to a nurse or other health worker, (iv) home visit by a nurse or other health worker’. 30 days post surgery
Primary Outcome Surgical site infection at 30-days post-surgery Several definitions for SSI exist, with the most widely used being that provided by the Centre for Disease Control (CDC). The following CDC definition will be used in FALCON to identify deep incisional or superficial incisional SSIs: 30 days post surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University for Development Studies School of Medicine and Health Sciences Tamale Teaching Hospital Hospital Road Tamale 00233 Ghana
Korle Bu Teaching Hospital Korle Bu Accra 00233 Ghana
Komfo Anokye Teaching Hospital Bantama Kumasi 00233 Ghana
Cape Coast Teaching Hospital University of Cape Coast Interbertin Cape Coast 00233 Ghana
Ho Teaching Hospital Hospital Road Ho 00233 Ghana
Holy Family Hospital Hospital Road Techiman 00233 Ghana
Sunyani Regional Hospital New Dormaa Road Sunyani 00233 Ghana
Methodist Hospital Hospital Road Wenchi 00233 Ghana
Holy Family Hospital Road Berekum 00233 Ghana
Salaga Municipal Hospital Hospital Road Salaga 00233 Ghana
Sandema District Hospital Hospital Road Sandema 00233 Ghana
St. Patricks Hospital Hospital Road Offinso 00233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute of Health Research Main Office London 0044 United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Birmingham Bedgbaston Birmingham 0044 United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
University for Development Studies School of Medicine and Health Sciences Tamale Teaching Hospital Hospital road Tamale 00233 Gibraltar
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dion Morton Dion.Morton@uhb.nhs.uk +44121371200 Edgbaston
City Postal code Country Position/Affiliation
Birmingham 0044 United Kingdom Barling Chair of Surgery and Director NIHR Global Health Research Unit on Global Surgery
Role Name Email Phone Street address
Scientific Enquiries Susan Cottam healthandsafety@contact.bham.ac.uk +441214158100 Edgbaston
City Postal code Country Position/Affiliation
Birmingham 0044 United Kingdom Birmingham University
Role Name Email Phone Street address
Public Enquiries Sohini Chakrabortee s.chakrabortee@bham.ac.uk +441213718121 Edgbaston
City Postal code Country Position/Affiliation
Birmingham 0044 United Kingdom Birmingham University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes A minimum summary results or a link to summary results within the trial would be shared within 12 months of completion Study Protocol Within 12 months of completion Controlled type
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information