Evaluating the Effects of Prontosan Wound Gel X on the Occurrence of Superficial Surgical Site Infections in Adult Cardiac Surgery Patients: A Single-Arm, Phase IV, Adaptive Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 456
- 试验地点
- 2
- 主要终点
- Occurrence of Superficial Surgical Site Infection (SSI)
研究概览
简要总结
This study aims to evaluate the effects of Prontosan® Wound Gel X on the incidence of superficial surgical site infections (SSI) in adult patients undergoing elective cardiac surgery with median sternotomy. The primary objective is to assess how the intraoperative application of the gel impacts the occurrence of SSIs, defined according to CDC/NHSN criteria. Secondary objectives include evaluating the length of hospital stay, the incidence of unplanned re-operations, and identifying any latent clinical subgroups through clustering analysis.
The study will be conducted as a prospective, single-center, observational, post-market trial. The primary endpoint will be the incidence of SSIs during the post-operative hospitalization period, while secondary endpoints will focus on hospital stay duration, re-operation rates, and feasibility indicators such as adherence to the protocol and completeness of data collection. The study also includes an exploratory endpoint where hierarchical clustering will be used to identify clinical subgroups based on demographic, clinical, and procedural variables.
Up to 456 adult patients will be enrolled, all of whom are undergoing elective cardiac surgery via median sternotomy at IRCCS Policlinico San Donato. The inclusion criteria include patients aged 18 or older, scheduled for surgery, and able to provide informed consent, with the clinical decision to use Prontosan® Wound Gel X during the surgery. Exclusion criteria involve urgent surgeries, participation in other interventional studies, known hypersensitivity to the gel components, or existing skin conditions incompatible with its use.
The study duration is estimated to be approximately 18 months, depending on patient enrollment and discharge rates. The follow-up will align with the hospital stay, from the surgery date to discharge, with no post-discharge follow-up planned. Statistical analysis will include a binomial test to compare observed SSI rates with those reported in literature, while secondary data will be analyzed descriptively. An exploratory analysis will use clustering to explore latent clinical subgroups.
详细描述
Background Surgical site infections (SSIs) remain one of the most frequent and impactful healthcare-associated infections (HAIs) in cardiac surgery, particularly in patients undergoing median sternotomy. Despite advancements in perioperative care and infection prevention protocols, SSIs continue to pose a substantial burden on postoperative recovery, patient safety, and healthcare systems.
Superficial SSIs, which involve the skin and subcutaneous tissues, represent a significant proportion of these infections and are often underestimated in terms of their clinical implications. According to global estimates, the incidence of superficial SSIs following cardiac surgery ranges from 5% to 12%, depending on the patient population, surgical complexity, and adherence to infection control measures (Cardiothoracic Interdisciplinary Research Network et al., 2024). In Italy, recent surveillance data suggest a comparable incidence, with rates in cardiac surgery patients undergoing sternotomy reaching approximately 10-12%, particularly in high-risk groups.
The clinical consequences of superficial SSIs are far from negligible. They are associated with prolonged hospital stays, increased use of antibiotics, elevated risk of wound dehiscence, and, in some cases, progression to deeper infections such as mediastinitis. Moreover, these complications may require additional surgical interventions and intensive care, further straining healthcare resources. Economically, SSIs impose a considerable cost burden on hospitals and national health systems. Extended hospitalizations and re-operations increase direct medical costs, while indirect costs related to loss of productivity and reduced quality of life further amplify the impact. Preventing even a modest proportion of SSIs could translate into substantial cost savings and improved patient outcomes.
The development of superficial SSIs following cardiac surgery is a multifactorial phenomenon influenced by a complex interplay of intrinsic patient characteristics, procedural variables, and anatomical considerations related to the surgical approach. Intrinsic risk factors include advanced age, elevated body mass index (BMI), and the presence of comorbid conditions such as diabetes mellitus, chronic obstructive pulmonary disease (COPD), peripheral vascular disease, and immunosuppression.
These factors could compromise wound healing, increase susceptibility to infection, and impair the host immune response, thereby predisposing patients to postoperative complications, including SSIs. Procedural factors also contribute substantially to infection risk. Prolonged operative time, excessive intraoperative bleeding, use of foreign materials (e.g., sternal wires or grafts), and the overall complexity of the surgical intervention are all associated with higher rates of SSIs. Moreover, suboptimal wound management practices, including insufficient skin antisepsis or improper application of dressings, may further elevate infection risk.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective cardiac surgery requiring median sternotomy (e.g., CABG, valve surgery, aortic surgery)
- •Ability to provide informed consent
- •Independent clinical decision by the treating surgeon to apply Prontosan Wound Gel X during surgery, irrespective of study enrollment
排除标准
- •Urgent or emergency surgery
- •Concurrent enrollment in interventional clinical trials
- •Known hypersensitivity to components of Prontosan Wound Gel X
- •Local skin conditions or infections at the planned incision site that preclude safe use of topical antiseptic products
结局指标
主要结局
Occurrence of Superficial Surgical Site Infection (SSI)
时间窗: From the day of surgery until hospital discharge, assessed for up to 30 days.
Superficial SSIs are defined according to CDC/NHSN criteria as infections involving only the skin and subcutaneous tissue of the incision, identified by purulent drainage, positive culture from the superficial incision, or clinical signs of infection with deliberate opening by a clinician. Occurrence is assessed through daily postoperative evaluations and confirmed by an independent infectious disease specialist.
次要结局
- Length of Hospital Stay(From the date of surgery to the date of hospital discharge, assessed for up to 30 days.)
- Incidence of Re-do Surgery(From the date of surgery until hospital discharge, assessed for up to 30 days.)
- Protocol Adherence(From intraoperative period through postoperative hospitalization until discharge, assessed for up to 30 days.)
- Data Completeness(Assessed from the intraoperative period through discharge, for up to 30 days.)
- Product-Related Adverse Events(From the day of surgery until discharge, assessed for up to 30 days.)
- Length of Hospital Stay(From the date of surgery to the date of hospital discharge, assessed for up to 30 days.)
- Incidence of Re-do Surgery(From the date of surgery until hospital discharge, assessed for up to 30 days.)
- Protocol Adherence(From intraoperative period through postoperative hospitalization until discharge, assessed for up to 30 days.)
- Data Completeness(Assessed from the intraoperative period through discharge, for up to 30 days.)
- Acceptability of Gel Use(From intraoperative period through postoperative hospitalization until discharge, for up to 30 days.)
- Product-Related Adverse Events(From the day of surgery until discharge, assessed for up to 30 days.)