Surgery

CLEAN Joint Trial - CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee – A Vanguard Randomized Controlled Registry Trial

Principal investigator
Dr. Raman Mundi, Sunnybrook Health Sciences

Recruitment Status
Recruiting

Summary
The CLEAN Joint trial is a pragmatic, open label, 2-arm parallel-group pilot randomized controlled trial that is planned to simulate all aspects of a larger definitive trial. Patients scheduled to undergo aseptic revision THA or revision TKA will be randomly assigned to receive surgical antiseptic skin preparation with either chlorhexidine or iodine-based solution.

The main outcome of interest is the need for re-operation for a wound complication or an infection of the prosthetic joint within one year after surgery. Other key outcomes are surgical site infection, mortality, and readmission to hospital.

ClinicalTrials.gov (NCT#)
NCT05828810

Trial email
CLEANJoint@sunnybrook.ca

Trial Locations
Toronto, ON, Canada

IMPACTS - The Innovative, Multicentre, Patient-centred Approach to Clinical Trials in Surgery (IMPACTS) Program

Principal investigator
Dr Paul Karanicolas, Sunnybrook Health Sciences Centre

Recruitment Status
Recruiting

Summary
IMPACTS is a platform of pragmatic trials that are integrated into routine clinical care. Key elements of the methodology include: enrollment using an integrated consent model that incorporates oral consent, leveraging of existing data collection registries to minimize additional data collection, patient-reported outcome measures, and an adaptive design that allows for removal of arms and stopping of the trial when efficacy or equivalence targets are met.

The IMPACTS pilot trials aim to demonstrate feasibility of the platform according to pre-defined objectives related to enrollment, ability to deliver the interventions, and collect outcome data. The trials are:

The CLEAN Wound Trial
This trial aims to determine if intraoperative incisional wound irrigation with povidone-iodine solution or saline prevents surgical site infections when compared to no irrigation.

The ICE Trial
This study examines whether cryotherapy (cold therapy) improves the quality of patients’ post-operative recovery and pain compared to no cryotherapy.

The COFFEE Trial
This trial aims to determine if coffee/caffeine can improve post-operative gastrointestinal recovery.

PARFAIT
This trial examines whether the use of antibiotics prevents fistula formation in patients with perianal abscesses following incision and drainage.

ClinicalTrials.gov (NCT#)

Trial email
impactsprogram@sunnybrook.ca

Trial Locations
Toronto, ON, Canada
Ottawa, ON, Canada

Links
Study Website
X Profile

1. CLEAN Wound Trial: NCT04548661
2. ICE Trial: NCT04564963
3. COFFEE Trial: NCT04547868
4. PARFAIT: NCT04549311

PERQ-UP - Pancreatic Enzyme Replacement Therapy to Improve Quality of Life in Patients Undergoing Pancreaticoduodenectomy: A Pilot Randomized Controlled Trial

Principal investigator
Dr Paul Karanicolas, Sunnybrook Health Sciences Centre

Recruitment Status
Recruiting

Summary
PERQ-UP is a pilot, multi-centre, pragmatic randomized controlled trial that is planned to simulate all aspects of a larger definitive trial comparing early initiation of pancreatic enzyme replacement therapy (PERT) immediately after pancreaticoduodenectomy (PD) versus standard of care initiation of PERT upon symptom presentation for the treatment of pancreatic enzyme insufficiency (PEI), in appropriately selected patients.

The primary outcome measures for the pilot trial are to determine feasibility. Specifically, to: 1) determine the proportion of patients screened who meet eligibility criteria and consent; 2) assess adherence with PERT after 3-months; 3) assess adherence with PERT dosing guidelines; 4) examine our ability to collect complete perioperative and follow-up data to 3-months; and 5) determine resource requirements to conduct a definitive trial. The pilot aims to enroll 100 participants across 6 sites in Ontario. The definitive study will enroll an additional 300 participants across Canada.

ClinicalTrials.gov (NCT#)
NCT05466838

Trial email
PERQ-UP@sunnybrook.ca

Trial Locations
Toronto, Ontario; Hamilton, Ontario; London, Ontario; Kingston, Ontario; Ottawa, Ontario

PRIMe - The HepatoPancreaticoBiliary Resection Arginine Immunomodulation

(PRIMe) Trial: A Randomized Phase II Trial of the Impact of Perioperative Immunomodulation on Immune

Function following Resection for HepatoPancreaticoBiliary Malignancy

Principal investigator
Dr Paul Karanicolas, Sunnybrook Health Sciences Centre

Recruitment Status
Completed

Summary
This is a randomized controlled blinded superiority trial to evaluate the impact of perioperative immunosupplementation on NK-cell function following resection of HPB malignancies. Two variations of immunosupplementation will be compared to control nutritional supplement containing whey protein with an additional tsp of placebo oil. These variations will be 1) a powdered formula containing whey protein and arginine (Active A) with an additional teaspoon (tsp) of lipid bolus containing omega-3 fatty acids, and 2) a powdered formula containing whey protein and arginine (Active A) with an additional tsp of placebo oil which does not contain omega-3 fatty acids. 45 participants will be enrolled.

The primary outcome is reduction in NK cell killing as measured on post-operative day 1 as compared to baseline (pre-operative) between the control and experimental cohorts. A flow cytometry-based killing assay will be used which can specifically measure NK cell cytotoxicity by utilizing fluorescent cell dyes to distinguish between live or dead Effector cells (the patient PBMCs or the control NK92 cell line) and target cells (the K562 erythroleukemia cell line). Arginine supplementation will be considered effective at reducing postoperative NK cell dysfunction if there is a 50% or greater improvement in postoperative suppression of NK cell cytotoxicity (reduction of 27% from baseline).

ClinicalTrials.gov (NCT#)
NCT04549662

Trial email
PRIME@sunnybrook.ca

Trial Locations
Toronto & Ottawa, Ontario