As of August 1st, 2023, the CLEAN Wound Trial is officially open for enrollment at two sites:
- Sunnybrook Health Sciences Centre
- Hamilton Health Sciences – Juravinski Hospital
Our CIHR Operating Grant: Clinical Trials Projects application, entitled “The Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation (CLEAN Wound) Trial” was successful in securing funding to support the definitive CLEAN Wound Trial at our 3 existing pilot sites and several new sites across Ontario!
More information about the CIHR’s Clinical Trials Fund can be found here and a full list of funded projects is available here.
Additional news releases about CLEAN Wound can be found using the links below:
- Sunnybrook Research Institute Research News
- CIHR Celebrating Health Research: The faces of health research 2023
Full trial details are available on ClinicalTrials.gov
In this episode of the ON-SQIN podcast Surgical 411, members of the North York General Hospital surgical quality improvement team talk about their quality improvement journey and their experience taking part in the multi-hospital IMPACTS Program trials.
It is available to listen here:
The IMPACTS Program will officially be launching 4 trials in October 2021 at 3 sites in Ontario (Sunnybrook Health Sciences Centre, North York General Hospital and The Ottawa Hospital)!
These trials will run for 1 year, to evaluate the feasibility of conducting multiple trials in surgical and perioperative care using the innovative IMPACTS Program framework.
Here are the 4 questions that will be examined:
1- Does the use of antibiotics prevent re-intervention and fistula formation in patients with perianal abscesses, following incision and drainage?
2- Can cryotherapy improve the quality of patients’ post-operative recovery and pain?
3- Does wound irrigation prevent surgical site infections?
4- Can coffee/caffeine improve post-operative gastrointestinal recovery?
For more information on each of the IMPACTS trials, click here.
Given the COVID-19 pandemic, our start date has been delayed, but at this point, we anticipate launching the initial IMPACTS trials in the fall of 2021. More details on the trials will be shared here on our website, as we get closer to the launch.
In the meantime, here is an outline of our progress in the last year:
- Development & REB approval of trial protocols
- REDCap database development & bio statistical simulations
- Clinician training material development
- Final site selection, engagement and contracts
- CIHR Project Grant submission
- Additional systematic review publication
The IMPACTS team’s first systematic review, entitled: The impact of negative pressure wound therapy for closed surgical incisions on surgical site infection: A systematic review and meta-analysis has been published in SURGERY.
This systematic review and meta-analysis of randomized clinical trials examines whether negative pressure wound therapy compared with conventional dressings in all surgical patients with primarily closed incisions reduces the incidence of surgical site infection and other wound complications.
In press: https://doi.org/10.1016/j.surg.2020.01.018
Which trials have we selected to move forward with?
- Wound irrigation to prevent SSIs
- Coffee to reduce post-operative ileus
- Regional nerve blocks (+/- ice packs) to reduce postoperative pain and narcotic use
- Abscess packing (vs. no packing) for wound healing, pain and fistula formation.
What are the next steps?
We are in the process of establishing steering committees (composed of a content expert, a methodological expert, a resident lead, a patient lead, etc.) and selecting the potential sites for pilot trials to demonstrate the feasibility of this novel approach. We have also begun developing the trial protocols and the research infrastructure to conduct pragmatic clinical trials (i.e., an umbrella research ethics board protocol, creation of data linkages between existing data collection mechanisms, and web-based randomization and integrated consent). We are continuing to search for other potential trial questions and to systematically review the evidence surrounding them.
How can you get involved?
If you would like to get involved with the IMPACTS program in any capacity, please contact paul.karanicolas@sunnybrook.ca and we would be happy to explore possibilities with you!
In May 2019 we held two workshops with members of key stakeholder groups; including patient and family partners, healthcare professionals, and policy-makers to present trial questions and collect feedback about which ones to prioritize for development into clinical trials. The trial questions that were presented and discussed targeted outcomes which included: post-operative delirium, pain, surgical site infections, and quality of life. Participants were asked to assess each of the potential trials in terms of their clinical impact, feasibility, and applicability. The level of engagement and the constructive input that we received was invaluable for informing next steps – the selection of the first set of IMPACTS trials!
