Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation
Study Details
Study Description
Brief Summary
Following a surgical procedure, patients may experience complications, such as a surgical site infection (SSI). The Centers for Disease Control and Prevention (CDC) define a SSI as an incisional or organ space infection which occurs following a surgical procedure. The severity is then classified as a superficial, deep or organ space infection, occurring within 30 days of surgery. Despite improvements in patient care and a variety of available preoperative, intraoperative and postoperative infection prevention strategies, SSIs still occur very frequently. They account for 20% of hospital infections and are associated with important economic and patient outcomes such as morbidity, mortality and length of stay. It is estimated that over half (55%) of SSIs could be prevented. One proposed intervention to reduce SSIs is the intraoperative irrigation of incisional wounds. By washing a solution over an open wound, debris, bacteria and bodily fluids may be removed prior to wound closure at the end of a procedure. Although many studies have been conducted, uncertainty remains with respect to the following: 1) the need for irrigation; 2) the solution used to irrigate; 3) the method of irrigation (i.e. pour, syringe, pressure and/or pulsed delivery); and 4) the volume of irrigation, leading to conflicting guidelines and practice heterogeneity. In this trial, adult patients scheduled to undergo an elective abdominal 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. This trial will be conducted under the IMPACTS (Innovative, Multicentre, Patient-centred Approach to Clinical Trials in Surgery) program umbrella and will follow IMPACTS methodology. For the Vanguard trial, the aim is to determine the feasibility of conducting a definitive trial. Future outcomes of interest include surgical site infection and quality of life, among others.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Background/Rationale: Recent international Guidelines and reviews have highlighted that studies of intraoperative irrigation are small, outdated (i.e., no longer reflect current standards of care), and judged to be of very low to moderate quality, and have called for additional RCTs.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 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. Further evidence is 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 is optimal for this practice. We aim to address this knowledge gap by assessing the benefit of intraoperative wound irrigation with povidone-iodine solution as compared to with saline, or no irrigation in adults aged 18 years or older who are scheduled to undergo an elective abdominal surgery.
Objectives: Before embarking on a definitive RCT, this pilot trial has five specific feasibility objectives:
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To assess our ability to accrue patients using the IMPACTS Program design platform at multiple institutions, over the course of one year.
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To assess our ability to adaptively randomize patients and deliver the randomized assignment using the IMPACTS Program design platform, over the course of one year.
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To assess our ability to collect complete data directly from participants (patients and clinicians) on: surgical site infection and quality of life over the course of one year.
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To examine our ability to carry out data linkages using the IMPACTS Program design platform over the course of one year.
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To estimate the rate of surgical site infections to inform the sample size calculation for the definitive trial.
Study design: This is a multicenter, pragmatic, open-label, 3-arm Vanguard 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. Participants will be followed until 30 days after surgery to assess the incidence of SSIs, with additional outcomes collected until 90 days after surgery. If feasibility is demonstrated during the pilot trial, we will plan to conduct a definitive trial. If there are only minimal changes to the protocol, we will include data from the pilot phase into the definitive trial analysis (i.e. a Vanguard design).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Povidone-iodine solution
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Procedure: Intraoperative incisional wound irrigation with povidone-iodine solution
Participants will have the open incision or laparoscopic extraction site irrigated once with povidone-iodine diluted in 0.9% sterile normal saline (to a final concentration of 5% povidone-iodine (0.5% available iodine)) delivered through a bulb syringe. The povidone-iodine irrigation should be left on for 60 seconds and then dried with sterile gauze. Irrigation will be performed after any/all deep tissue layers are closed, prior to skin closure. The volume used will be left to the discretion of the clinician and irrigation will be administered until saturation is achieved.
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| Placebo Comparator: Saline
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Procedure: Intraoperative incisional wound irrigation with saline
Participants will have the open incision or laparoscopic extraction site irrigated once with 0.9% sterile normal saline delivered through a bulb syringe. Irrigation will be performed after any/all deep tissue layers are closed, prior to skin closure. The volume used will be left to the discretion of the clinician and irrigation will be administered until saturation is achieved.
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| No Intervention: No irrigation Standard incision management |
Outcome Measures
Primary Outcome Measures
- Assessment of accrual (one year) [1 year]
Average number of patients enrolled per month across multiple sites for the trial: feasible if 10 or more overall.
- Ability to deliver the intervention that the participant is randomized to receive [1 year]
Feasible if >90% of participants receive the correct intervention
- Ability to collect complete data for patient-reported outcomes [1 year]
Feasible if >80% of data is collected.
- Ability to link data from patient-reported outcome measures with Institute for Clinical Evaluative Sciences (ICES) and National Surgical Quality Improvement Program (NSQIP) datasets [1 year]
Feasible if linkage is possible in >90% of participants
- Estimation of surgical site infections (SSIs) [1 year]
Number of SSIs within 30 days of surgery in each group
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults aged 18 years or older;
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Scheduled to undergo an open or laparoscopic elective procedure with a planned extraction site ≥3 cm;
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Surgical procedure considered to be a laparotomy or have a groin incision; and
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Anticipated CDC wound classification I (clean), II (clean-contaminated) or III (contaminated).
Exclusion Criteria:
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Laparoscopic procedures without a planned extraction site;
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Known or anticipated CDC wound classification IV (dirty); and
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Contraindication to receiving povidone-iodine irrigation (i.e. known allergy).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | North York General Hospital | North York | Ontario | Canada | M2K 1E1 |
| 2 | The Ottawa Hospital | Ottawa | Ontario | Canada | K1H 8L6 |
| 3 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
Sponsors and Collaborators
- Sunnybrook Health Sciences Centre
Investigators
- Principal Investigator: Paul Karanicolas, MD PhD, Sunnybrook Health Sciences Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTO Project ID: 2123