Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation

Summary

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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Recent international Guidelines and reviews have highlighted that studies of intraoperative irrigation are small, outdated (i.e., no longer reflect current standards of care), and judged to be of very low to moderate quality, and have called for additional RCTs.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...

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Recent international Guidelines and reviews have highlighted that studies of intraoperative irrigation are small, outdated (i.e., no longer reflect current standards of care), and judged to be of very low to moderate quality, and have called for additional RCTs.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: To assess our ability to accrue patients using the IMPACTS Program design platform at multiple institutions, over the course of one year. 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. 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. To examine our ability to carry out data linkages using the IMPACTS Program design platform over the course of one year. 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).

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