Elsevier

Journal of Surgical Research

Volume 265, September 2021, Pages 64-70
Journal of Surgical Research

Initial Outcomes of a Novel Irrigating Wound Protector for Reducing the Risk of Surgical Site Infection in Elective Colectomies

https://doi.org/10.1016/j.jss.2021.02.054Get rights and content

Highlights

  • Colorectal surgery continues to suffer a high surgical site infection rate.

  • Device combining intraoperative wound protection and irrigation has been developed.

  • Clinical assessment of the novel device was analyzed.

  • Surgical site infection rates were reduced when the novel device was utilized.

ABSTRACT

Background

Surgical site infection (SSI) rates in elective colorectal surgery remain high due to intraoperative exposure of colonic bacteria at the surgical site. We aimed to evaluate 30-day SSI outcomes of a novel wound retractor that combines barrier protection with continuous wound irrigation in elective colorectal resection.

Materials and methods

A retrospective single-center cohort-matched analysis included all patients undergoing elective colorectal resection utilizing the novel irrigating wound protector (IWP) from April 2015 to July 2019. A control cohort of patients who underwent the same procedures with a standard wound protector over the same time period were also identified. Patients from both groups were matched for procedure type, procedure approach, pathology requiring operation, age, sex, race, body mass index, diabetes, smoker status, hypertension, presence of disseminated cancer, current steroid or immunosuppressant use, wound classification, and American Society of Anesthesiologist classification. SSI frequency, SSI subtype (superficial, deep, or organ space), hospital length of stay (LOS) and associated procedure were tabulated through 30 postoperative days. Fisher's exact test and number needed to treat (NNT) were used to compare SSI rates and estimate cost between both groups.

Results

The IWP group had 41 patients. The control group had 82 patients. Control-matched variables were similar for both groups. 30-day SSI rates were significantly lower in the IWP group (P=0.0298). length of stay was significantly shorter in the IWP group (P=0.0150). The NNT for the IWP to prevent one episode of SSI was 8.2 patients.

Conclusions

The novel IWP device shows promise to reducing the risk of SSI in elective colorectal surgery.

Introduction

Surgical site infection (SSI) remains a persistent and morbid problem affecting colorectal patients at a high rate of 7%-25%.1, 2, 3, 4, 5, 6 The negative outcomes of an SSI include a significant increase in morbidity, length of hospital stay, readmissions, and healthcare-associated cost as well as an overall decrease in patient satisfaction.7, 8, 9, 10 Thus, strategies to reduce the incidence of SSI following colorectal surgery are important for improving outcomes and reducing healthcare costs in the surgical patient. Numerous and varied evidence-based strategies have been implemented with variable degrees of successfully reducing SSI rates.11, 12, 13, 14

The mechanisms underlying SSI development represent a multifactorial process; however, the degree of intraoperative bacterial contamination in the surgical wound is arguably the most fundamental contributor to SSI pathogenesis.15 As strategies to decrease the effects of contamination have evolved, a number of techniques and technologies including the use of barrier wound protectors, intraperitoneal lavage, and end-of-case wound irrigation have each been shown to independently contribute to improvements in SSI rates, albeit to varying degrees.13,16,17

In an attempt to synthesize and standardize these anti-contamination strategies, a novel wound retractor device (CleanCision – Prescient Surgical, San Carlos, CA) that combines barrier protection and integrated antibiotic irrigation has recently been developed. Previous studies with this irrigating wound protector (IWP) have demonstrated significant reductions in microbial inoculation at the surgical wound site by 66% at the time of surgical site closure in addition to suppression of microbial growth for up to 4 hours postoperatively in both human and large animal studies, respectively.12,18 Another study demonstrated a 61% relative risk reduction in SSI when comparing similar cases to generalized NSQIP data.19 However, the cost of the new IWP at our institution is nearly 9 times more expensive than a more conventional wound protector (Alexis – Applied Medical, Rancho Santa Margarita, CA) that has also demonstrated significant SSI reductions.20,21 At our institution, both the IWP and the conventional barrier wound protector have been available for use by our colorectal surgeons since 2015. However, no prior studies have attempted to directly compare SSI outcomes of the new IWP with the conventional wound protector in the clinical setting. We aimed to compare 30-day SSI rates, hospital length of stay, and cost utilization for both retractors in the setting of elective colorectal resections.

Section snippets

Methods

A single-center retrospective cohort-matched study was performed in patients undergoing colorectal resection between April 2015 and July 2019 at the flagship tertiary care hospital for the Baylor Scott & White Health – Central Texas region located in Temple, TX. All patients undergoing elective colorectal resection with intraoperative use of the CleanCision (Prescient Surgical, San Carlos, CA) IWP device (Fig. 1) were included in the study. The study was approved by the Baylor Scott & White

Results

A total of 41 patients were identified for the IWP group. A total of 1164 potential control patients were identified as having an elective colorectal resection with a primary CPT code that matched one within the IWP group. Per the 2:1 matching algorithm, 82 patients were identified in the matched control group. Both groups had similar preoperative patient profiles (Table 1) and procedural characteristics (Table 2), including age, sex, BMI, preoperative comorbidities, surgical indication, type

Discussion

SSI remains a vexing problem in colorectal surgery, likely due to its multifactorial pathogenesis involving both patient predisposition as well as perioperative risk factors. Much effort has been undertaken to develop consistent strategies to reduce the modifiable procedural and postoperative risk factors for SSI during colorectal procedures, including the concept of “bundling” a set of evidence-supported processes in to enhanced recovery pathways – such as the use of separate sterile closure

Conclusions

The new IWP technology shows preliminary promise at reducing the SSI rate and potential cost in elective colorectal surgery. Further large-scale prospective studies should provide more conclusive evidence on its effect on SSI risk reduction in colorectal surgery.

Authorship

All authors attest that they meet the current ICMJE criteria for authorship. Specific contributions are listed here:

Study design: Adil Malek, Harry Papaconstantinou, Scott Thomas.

Data acquisition: Adil Malek, Scott Thomas.

Analysis and data interpretation: Adil Malek.

Critical revision: all authors.

Acknowledgments

The authors would like to thank Lauren Sager at the Baylor Scott & White Health Research Institute for their support with study design and statistical analysis.

Conflict of interest

All authors have nothing to disclose. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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