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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04096885 -
The Inselspital Surgical Cohort Study
|
||
Terminated |
NCT03820648 -
Wound Protector Dual-ring Alexis® in Pancreaticoduodenectomy
|
N/A | |
Completed |
NCT04067843 -
Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study
|
N/A | |
Terminated |
NCT04042077 -
Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections
|
Phase 3 | |
Completed |
NCT05841576 -
Anaesthetic Management Guided by COMET Measurements
|
N/A | |
Withdrawn |
NCT05338281 -
NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT
|
N/A | |
Recruiting |
NCT03042091 -
Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery
|
Early Phase 1 | |
Completed |
NCT01697748 -
Prospective Study on Cesarean Wound Outcomes
|
N/A | |
Terminated |
NCT01789697 -
Text Message Study
|
N/A | |
Recruiting |
NCT05966961 -
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
|
||
Recruiting |
NCT05077592 -
Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections
|
Phase 4 | |
Recruiting |
NCT05502380 -
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
|
Phase 3 | |
Recruiting |
NCT05763602 -
PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)
|
Phase 4 | |
Recruiting |
NCT03221023 -
Intrawound Vancomycin Prophylaxis for Neural Stimulator
|
Phase 2/Phase 3 | |
Completed |
NCT03257202 -
Topical Treatment and Prevalence of P. Acnes
|
Phase 2 | |
Completed |
NCT06154720 -
Surgical Site Infection After Episiotomy Repair Related to Routine Use of Antibiotic Prophylaxis in Low-Risk Population
|
||
Not yet recruiting |
NCT06465901 -
A Stratified, Multi-ARm, muLti-site Randomised Platform Trial Aiming to Reduce the INcidence of Post-operative SSI
|
N/A | |
Not yet recruiting |
NCT04820075 -
Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery
|
N/A | |
Recruiting |
NCT03561376 -
Zinc Oxide Versus Petrolatum Following Skin Surgery
|
Early Phase 1 | |
Not yet recruiting |
NCT04496180 -
Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy
|
N/A |