Impact of Polyhexanide Care Bundle on Surgical Site Infections in Paediatric and Neonatal Cardiac Surgery: A Propensity Score‐Matched Retrospective Cohort Study

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Congenital heart disease undergoing paediatric and neonatal cardiac surgery (n=226). Intervention: Polyhexamethylene biguanide (PHMB) care bundle vs. Conventional care (standard preoperative cleansing with soap and water, routine perioperative povidone-iodine or chlorhexidine, and standard postoperative wound care). Primary outcome: Occurrence rate of surgical site infections (SSIs) within 30 days post-operation or up to 1 year if an implant was used (p=0.048).

Q: What does this research mean for the field?

Implementation of a polyhexamethylene biguanide (PHMB) care bundle significantly reduces the incidence of surgical site infections in paediatric and neonatal cardiac surgery compared to conventional care. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.ESTABLISHES_NEW_DIRECTION.

Gianluca Castiello; Giuseppe Caravella; Greta Ghizzardi; Gianluca Conte; Arianna Magon; Tiziana Fiorini; Laurenzia Ferraris; Simona De Vecchi; Veronica Calorenne; Andreea Alina Andronache; Alessandro Varrica; Alessandro Giamberti; Antonio Saracino; Rosario Caruso

doi:10.1111/iwj.70710

June 1, 2025International Wound JournalOpen Access

Impact of Polyhexanide Care Bundle on Surgical Site Infections in Paediatric and Neonatal Cardiac Surgery: A Propensity Score‐Matched Retrospective Cohort Study

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Key result

PHMB care bundle linked to ~75% fewer surgical site infections in paediatric cardiac surgery.

P=0.048
n=226

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Why the study?

To evaluate the impact of a polyhexamethylene biguanide care bundle on surgical site infections in paediatric and neonatal cardiac surgery, addressing a gap in paediatric-specific infection prevention protocols.

Does a polyhexamethylene biguanide (PHMB) care bundle reduce the occurrence of surgical site infections compared to conventional care in paediatric and neonatal patients undergoing cardiac surgery?

Key Points

To assess the effect of a polyhexamethylene biguanide (PHMB) care bundle on surgical site infection rates in paediatric and neonatal cardiac surgery.
Retrospective cohort study of patients younger than 18 years undergoing cardiac surgery at a single centre in Italy.
Compared Cohort A receiving the PHMB care bundle (n = 117, April to December 2023) against Cohort B receiving conventional care (n = 801, September 2020 to March 2023).
Applied 1:1 propensity score matching to balance baseline covariates, yielding 114 patients in Cohort A and 112 patients in Cohort B.
Surgical site infections were significantly lower in the PHMB group than in the conventional care group (1.8% vs. 7.1%, p = 0.048).
Postoperative median ICU stay was 2 days in both groups (p = 0.745), and median surgical ward stay was 16 days in Cohort A versus 13 days in Cohort B (p = 0.256).
Postoperative ECMO usage was 2.7% in each cohort (p = 0.991), and open sternum rates did not differ significantly (78.1% vs. 82.1%, p = 0.549).

Study Design

Type

Cohort (n=226)

Multicenter

No

Structured PICO

Does a polyhexamethylene biguanide (PHMB) care bundle reduce the occurrence of surgical site infections compared to conventional care in paediatric and neonatal patients undergoing cardiac surgery?

P

Population

226 propensity score-matched paediatric patients under 18 years old (median age 2.1 to 2.65 years) with congenital heart disease undergoing cardiac surgery via sternotomy or thoracotomy in Italy, followed for 30 days post-operation (or up to 1 year with implants).

E

Exposure

Polyhexamethylene biguanide (PHMB) care bundle from April to December 2023, comprising: (1) specialised educational program for healthcare professionals (nurses, surgeons, anaesthesiologists) on SSI prevention; (2) preoperative antimicrobial cleansing on the day before surgery using PHMB and surfactant-formulated wipes without rinsing, followed by clean gowns and linens; (3) intraoperative application of PHMB-based wound gel before dressing the surgical wound; and (4) standard dressings without topical negative pressure dressings.

C

Comparator

Conventional care (from September 2020 to March 2023), involving standard preoperative cleansing with soap and water, routine perioperative antiseptic preparation using agents such as povidone-iodine or chlorhexidine, and standard postoperative wound care without specialised PHMB interventions or structured educational programs targeting SSI prevention.

O

Outcome

Occurrence rates of surgical site infections (SSIs), defined following CDC guidelines as infections occurring at or near the surgical incision within 30 days post-operation or up to 1 year if an implant was used, collected prospectively through continuous surveillance at primary admission, readmission, and post-discharge.hard clinical

Main Result

Absolute Event Rate: 1.8% vs 7.1%

p-value: p=0.048

Implementing a comprehensive polyhexamethylene biguanide (PHMB) antimicrobial care bundle significantly reduced surgical site infections from 7.1% to 1.8% in paediatric and neonatal patients undergoing congenital cardiac surgery.

Limitations

Retrospective design limits the ability to establish causality and leaves potential for residual unmeasured confounding
Propensity score matching and exclusion of non-compliant records reduced the sample size, potentially affecting statistical power and generalisability
Inability to isolate the specific impact of PHMB from antibiotics and other components included in the care bundle
Single-centre setting limits applicability to other institutions
Potential variations in implementation and compliance with the care bundle

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Implication

PHMB bundle may lower SSIs in paediatric cardiac surgery; leaves open confirmation in randomized trials.

Abstract

The primary aim of this study was to evaluate the impact of the polyhexamethylene biguanide (PHMB) care bundle on the occurrence rates of surgical site infections (SSIs) in paediatric and neonatal cardiac surgery, addressing a critical gap in paediatric-specific infection prevention protocols. A retrospective cohort study included patients under 18 years old who underwent cardiac surgery at IRCCS Policlinico San Donato. Cohort A (n = 117) received the PHMB care bundle from April to December 2023, while Cohort B (n = 801) received conventional care from September 2020 to March 2023. The 1:1 propensity score matching was used to balance covariates between cohorts, resulting in two comparable cohorts (Cohort A = 114 patients and Cohort B = 112). The study found a significant reduction in SSIs among patients receiving the PHMB care bundle compared with those receiving conventional care (1.8% vs. 7.1%, p = 0.048). The comprehensive nature of the PHMB care bundle, including educational programs, preoperative and postoperative antimicrobial treatments, and consistent application of best practices, was instrumental in achieving these outcomes. Implementing antimicrobial care bundles could significantly reduce SSIs in paediatric cardiac surgery. Future research is needed to refine the tested bundle with prospective approaches.

Discussion

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Cite This Study

Castiello et al. (2025) conducted a cohort in Congenital heart disease undergoing paediatric and neonatal cardiac surgery (n=226). Polyhexamethylene biguanide (PHMB) care bundle vs. Conventional care (standard preoperative cleansing with soap and water, routine perioperative povidone-iodine or chlorhexidine, and standard postoperative wound care) was evaluated on Occurrence rate of surgical site infections (SSIs) within 30 days post-operation or up to 1 year if an implant was used (p=0.048). The polyhexamethylene biguanide (PHMB) care bundle reduced surgical site infections compared with conventional care in paediatric cardiac surgery.

synapsesocial.com/papers/6a74f21f0aae7781f80328c9 https://doi.org/10.1111/iwj.70710

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Impact of Polyhexanide Care Bundle on Surgical Site Infections in Paediatric and Neonatal Cardiac Surgery: A Propensity Score‐Matched Retrospective Cohort Study

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Impact of Polyhexanide Care Bundle on Surgical Site Infections in Paediatric and Neonatal Cardiac Surgery: A Propensity Score‐Matched Retrospective Cohort Study

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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