J&J MedTech Joins Efforts to Define, Classify Surgical Site Outcomes

Johnson & Johnson MedTech today joined a worldwide effort to initiate a global standardized classification system for evaluating and reporting surgical site outcomes (SSOs). Experts from various surgical specialties and healthcare disciplines want to develop a standardized approach surgeons and wound care teams can use to more fully capture the scope and frequency of postoperative complications, in order to improve preventative measures.

Wound complications including infections, bleeding, wound reopenings, and fluid collections are a significant burden for patients and global healthcare systems. Despite the prevalence of these complications in perioperative care, post-operative wound outcomes are underreported,^1,2,3,4 and there is currently no comprehensive global standard for defining and monitoring these outcomes.

Johnson & Johnson MedTech is joining the effort to better define and standardize SSOs’ evaluation and measure associated outcomes.

“As long-time partners to surgeons and surgical teams around the world, we know firsthand the impact that surgical complications can have on patient outcomes and the overall cost of care globally,” said Nisha Johnson, president, Wound Closure and Healing & Biosurgery, Johnson & Johnson MedTech. “The industry is calling for consistent definitions, standard solutions that improve outcomes, and a comprehensive approach to reporting and data collection that helps advance healing and improve the surgery experience for patients.”

Expanding Beyond SSIs: Addressing Adverse Surgical Site Outcomes

Complications at the surgical wound site occur at higher rates than any other kind of adverse event in hospitalized patients,^5,6 responsible for more than 25% of surgical readmissions.

SSIs are common,⁷ can be dangerous⁸ and costly,^9,10,11 and are often the focus of wound complication reporting, accounting for up to 31% of all hospital-acquired infections.^12,13 However, SSIs are still underreported, largely due to improper and inconsistent identification methods among health systems.^14,15,16 These infections often relate to other post-surgical wound complications including wound breakdown, fluid accumulation, and localized bleeding.

“When most people think about wounds, they think about surgical site infections, but wounds can dehisce, seromas can form, and hematomas can appear. All of these things need to be brought together in a common language so that we can describe the surgical site outcome for every single operation that includes every single type of surgical incision,” said Giles Bond-Smith,* M.D., a general surgeon at NHS Oxford Trust. “I am thrilled to come together with other experts in the field from around the world to advance our common language in surgery with the aim of reducing the occurrence of surgical complications for patients.”

Expanding surveillance beyond only SSIs by including other complications can potentially support care teams so wound complications are more consistently captured and reported, enabling clinicians to focus on patient conditions and appropriate intervention and treatment.

“Clear definitions are the first step to attempt to classify all types of wound complications so that we can improve reporting to drive earlier intervention,” said Antonia Chen,** M.D., an orthopedic surgeon specializing in hip and knee replacements. “In orthopedic surgery, wound complications vary relative to other specialties, with significant focus on closure-related interventions to manage dehiscence. Creating a system that fits across all specialties to address surgical site outcomes throughout the body can drive global consistency in care standards that the industry is missing today.”

Digital solutions can help improve the surveillance of surgical wound complications. Johnson & Johnson MedTech’s Polyphonic digital ecosystem connects data across surgical technologies, robotics, and surgical software while leveraging the company’s global scale. Leveraging the Polyphonic ecosystem, Johnson & Johnson MedTech will explore patient monitoring based on new, standard reporting guidelines as determined in SSO classification.

“Digital is a bridge to getting patients more involved in their surgical care,” said Shan Jegatheeswaran, vice president, Digital, Johnson & Johnson MedTech. “Building on a foundation of standard definitions across the primary contributors to surgical site outcomes, digital solutions connecting surgical teams and patients can be used to encourage more reporting, better wound care management, and increased patient engagement. In the future, these kind of standard classification systems have the potential to enable more personalized models before, during, and after surgery.”

For more than a century, Johnson & Johnson has helped advance surgical care through its portfolio across wound closure, adjunctive hemostats, surgical stapling and instruments, robotics and digital solutions. Together, with clinicians and healthcare experts worldwide, the company is striving to better solve patient needs in metabolic and cardiovascular disease, cancer, and aesthetics and reconstruction. Through its expertise in Innovative Medicine and MedTech, Johnson & Johnson is positioned to innovate across a full spectrum of healthcare solutions in cardiovascular, orthopedics, surgery, and vision care.

* Dr. Bond-Smith is a paid consultant for Johnson & Johnson MedTech.

** Dr. Chen is a paid consultant for Johnson & Johnson MedTech.

References
¹ Taherpour, N., Mehrabi, Y., Seifi, A. et al. Epidemiologic characteristics of orthopedic surgical site infections and under-reporting estimation of registries using capture-recapture analysis. BMC Infect Dis 21, 3 (2021). https://doi.org/10.1186/s12879-020-05687-z
² Guest JF, Fuller GW, Griffiths B. Cohort study to characterise surgical site infections after open surgery in the UK’s National Health Service BMJ Open 2023;13:e076735. doi: 10.1136/bmjopen-2023-076735
³ Russo, P.L. et al. Improving surgical site infection prevention in Asia-Pacific through appropriate surveillance programs: Challenges and recommendation. Infection, Disease & Health, Volume 26, Issue 3, 198 – 207
⁴ Sandy-Hodgetts, K., Carville, K. and Leslie, G.D. (2015), Determining risk factors for surgical wound dehiscence: a literature review. Int Wound J, 12: 265-275. https://doi.org/10.1111/iwj.12088
⁵ Leape LL, Brennan TA, Laird N, et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med. 1991 Feb 7;324(6):377-84. doi: 10.1056/NEJM199102073240605.
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⁷ Centers for Disease Control and Prevention, National Healthcare Safety Network, Surgical Site Infection Event (SSI) Jan 2024 Accessed October, 2024 www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf.
⁸ World Health Organization. WHO Guidelines for Safe Surgery, 2009.
⁹ de Lissovoy G, Pan F, Patkar A, et al. Surgical Site Infection Incidence and Burden Assessment Using Multi-institutional Real-world Data. Poster presented at International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 14th Annual European Congress; November 5-8, 2011; Madrid, Spain.
¹⁰ Thompson KM, Oldenberg WA, Deschamps C, Rupp WC, Smith CD. Chasing zero: The drive to eliminate surgical site infections. Ann Surg. 2011;254:430-437.
¹¹ Anderson DJ, Podgorny K, Berrios-Torres SI, et al. Strategies to prevent surgical site infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014;35(6):605-627.
¹² Centers for Disease Control and Prevention, National Healthcare Safety Network, Surgical Site Infection Event (SSI) Jan 2024 Accessed October, 2024
https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pd
¹³ Gillespie, BM; Harbeck, E; Rattray, M; et al. Worldwide incidence of surgical site infections in general surgical patients: A systematic review and meta-analysis of 488,594 patients. International Journal of Surgery 95():p 106136, November 2021. | DOI: 10.1016/j.ijsu.2021.106136
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¹⁵ Richter V, Cohen MJ, Benenson S, Almogy G, Brezis M. Patient Self-Assessment of Surgical Site Infection is Inaccurate. World J Surg. 2017 Aug;41(8):1935-1942. doi: 10.1007/s00268-017-3974-y. PMID: 28271262.
¹⁶ Horgan, S., Saab, M.M., Drennan, J., Keane, D. and Hegarty, J., 2023. Healthcare professionals’ knowledge and attitudes of surgical site infection and surveillance: A narrative systematic review. Nurse education in practice, 69, p.103637.