Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04548661
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2020-09-08
Brief Title:
Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
CLinical Evaluation of Adults UNdergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation A Randomized Controlled Trial CLEAN Wound
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A surgical site infection SSI is an infection that occurs after a surgical procedure Despite a variety of infection prevention strategies SSIs still occur often and impose a significant burden on patients and the healthcare system Intraoperative irrigation or washing of the surgical incision before closure may reduce SSIs but this is uncertain
The Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation CLEAN Wound trial aims to determine if incisional wound irrigation with an antiseptic or salt water solution can reduce SSIs within 30 days of surgery compared to no wound irrigation 2500 patients aged 18 years or older who are planned to undergo an abdominal or groin open or laparoscopic procedure will be randomly assigned to incisional wound irrigation with povidone-iodine solution or incisional wound irrigation with saline or no irrigation and followed for 30 days after surgery to assess the incidence of SSIs with additional outcomes collected up to 90 days after surgery
Even with significant advances in medicine over the past decades there are still many fundamental issues in perioperative care that remain unclear due to lack of evidence If this trial were to demonstrate that intraoperative wound irrigation reduces the incidence of SSI these practice-changing findings could greatly benefit patients worldwide
The Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation CLEAN Wound trial aims to determine if incisional wound irrigation with an antiseptic or salt water solution can reduce SSIs within 30 days of surgery compared to no wound irrigation 2500 patients aged 18 years or older who are planned to undergo an abdominal or groin open or laparoscopic procedure will be randomly assigned to incisional wound irrigation with povidone-iodine solution or incisional wound irrigation with saline or no irrigation and followed for 30 days after surgery to assess the incidence of SSIs with additional outcomes collected up to 90 days after surgery
Even with significant advances in medicine over the past decades there are still many fundamental issues in perioperative care that remain unclear due to lack of evidence If this trial were to demonstrate that intraoperative wound irrigation reduces the incidence of SSI these practice-changing findings could greatly benefit patients worldwide
Detailed Description:
BackgroundRationale Recent international guidelines and reviews have highlighted that studies of intraoperative irrigation were conducted in small samples over 30 years ago and no longer reflect the standard of care judging the evidence to be of very low to moderate quality and have called for additional RCTs For example as per the WHO Guidelines RCTs are needed to assess frequently utilized irrigation solutions and their effect on SSI risk and state that a suitable alternative to povidone-iodine is currently unknown Furthermore determining whether irrigation with antiseptics and antibiotics can reduce SSIs was listed as a key research recommendation by NICE in addition to determining cost-effectiveness of the intervention Additional evidence is therefore required to support or refute the effectiveness of intraoperative irrigation in reducing SSIs and to address practice heterogeneity with a focus on establishing whether irrigation is needed and if so which solution should be used
Objectives The primary objective is to determine if intraoperative incisional wound irrigation with povidone-iodine or saline in participants undergoing surgery can reduce incisional SSIs within 30 days of surgery compared to no irrigation The secondary outcomes include quality of life QoL proportion of participants prescribed systemic antibiotics wound care received via home care services all within 30 days of surgery length of stay LOS during index hospitalization wound dehiscence requiring reoperation postoperative complications mortality and healthcare utilization all within 90 days of surgery including number of re-interventions ie radiologically guided drain insertion or revision number of all-cause reoperations number of all-cause emergency department visits number of all-cause family physician or walk-in clinic visits and number of all-cause readmissions and length of stay of each readmission
Study Design This is a multicentre pragmatic participant and adjudicator-blinded three-arm RCT Participants will be randomized using an adaptive design to incisional wound irrigation with povidone-iodine versus incisional wound irrigation with saline versus no irrigation and will be followed until 30 days after surgery to assess the incidence of SSIs with additional outcomes collected up to 90 days after surgery The trial is adaptive in that one of the arms may be discontinued as the trial progresses if it reaches a threshold for inferiority and will be a continuation of our pilot trial ie a vanguard design
Objectives The primary objective is to determine if intraoperative incisional wound irrigation with povidone-iodine or saline in participants undergoing surgery can reduce incisional SSIs within 30 days of surgery compared to no irrigation The secondary outcomes include quality of life QoL proportion of participants prescribed systemic antibiotics wound care received via home care services all within 30 days of surgery length of stay LOS during index hospitalization wound dehiscence requiring reoperation postoperative complications mortality and healthcare utilization all within 90 days of surgery including number of re-interventions ie radiologically guided drain insertion or revision number of all-cause reoperations number of all-cause emergency department visits number of all-cause family physician or walk-in clinic visits and number of all-cause readmissions and length of stay of each readmission
Study Design This is a multicentre pragmatic participant and adjudicator-blinded three-arm RCT Participants will be randomized using an adaptive design to incisional wound irrigation with povidone-iodine versus incisional wound irrigation with saline versus no irrigation and will be followed until 30 days after surgery to assess the incidence of SSIs with additional outcomes collected up to 90 days after surgery The trial is adaptive in that one of the arms may be discontinued as the trial progresses if it reaches a threshold for inferiority and will be a continuation of our pilot trial ie a vanguard design
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None