Comparison of Povidone-Iodine and Chlorhexidine in the Management of Iatrogenic Wounds in Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Numerical Rating Scale (NRS)
研究概览
简要总结
This comparison examines the effectiveness of povidone-iodine and chlorhexidine in managing iatrogenic wounds in surgical patients. Both antiseptics are commonly used to prevent postoperative infections, but they differ in mechanism, efficacy, and safety profiles. Povidone-iodine releases iodine, which acts broadly against bacteria, viruses, and fungi, while chlorhexidine disrupts cell membranes, providing rapid bactericidal action. Studies suggest that chlorhexidine may offer longer-lasting antibacterial effects, but povidone-iodine has a wider antimicrobial range. Optimal choice depends on patient needs, wound type, and potential for adverse reactions, emphasizing the need for tailored antiseptic strategies in wound care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly patients undergoing surgical procedures resulting in iatrogenic wounds (surgical wounds of various specialties, such as abdominal, orthopedic, cardiovascular, etc.).
- •Availability for follow-up during the postoperative period, ensuring attendance at medical check-ups for the evaluation of healing and prevention of infections.
- •Ability to provide informed consent, understanding the objectives, risks and benefits of the study.
- •Absence of previous infections at the surgical site, ensuring that the wounds are recent and derived from the current surgical procedure.
排除标准
- •Known allergies or hypersensitivity to povidone iodine or chlorhexidine, to avoid risks of serious adverse reactions.
- •Immunocompromised patients, such as those with advanced HIV, on immunosuppressant treatment, or with decompensated chronic diseases (poorly controlled diabetes, kidney failure, etc.), due to increased susceptibility to infections and altered healing.
- •Patients with active infections or infected wounds prior to surgery, to avoid biasing the results by pre-existing infections.
- •Pregnancy or breastfeeding, due to safety considerations and the possible alteration of healing and immunity processes during these stages.
- •Use of other antiseptics or topical treatments at the wound site that may interfere with the efficacy of povidone iodine or chlorhexidine.
- •Patients with known wound healing disorders (such as autoimmune diseases or hematological disorders), which may affect the results in terms of healing time and quality.
结局指标
主要结局
Numerical Rating Scale (NRS)
时间窗: Up to twelve weeks
The Numerical Rating Scale is a pain assessment tool where patients rate their pain intensity on a scale from 0 to 10, with 0 indicating "no pain" and 10 representing "the worst possible pain." The interpretation of the scores is categorized into levels of pain severity: a score of 0-3 denotes mild pain, 4-6 indicates moderate pain, and 7-10 reflects severe pain. This categorization allows healthcare providers to gauge the patient's pain experience effectively, guiding treatment decisions and evaluating the efficacy of pain management strategies.
EuroQol-5D (EQ-5D)
时间窗: Up to twelve weeks
The EuroQol-5D is a standardized instrument for measuring health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The results yield a single index score that typically ranges from -0.594 (worse than death) to 1 (optimal health). Scores are interpreted as follows: 0.0 signifies an average quality of life, 0.5 to 0.8 indicates moderate impairment, and 0.9 to 1.0 reflects high quality of life. These scores are essential for assessing the impact of interventions on patient quality of life.
Patient Satisfaction Questionnaire (PSQ)
时间窗: Up to twelve weeks
The Patient Satisfaction Questionnaire assesses patient satisfaction with healthcare services, using a scale from 1 to 5, where 1 represents "very dissatisfied" and 5 indicates "very satisfied." Interpretation of the scores categorizes satisfaction levels: 1-2 denotes low satisfaction, 3 represents average satisfaction, and 4-5 indicates high satisfaction. Higher scores suggest improvements in service quality and patient care, providing valuable feedback for healthcare providers to enhance their practices.
Wound Healing Assessment Tool
时间窗: Up to twelve weeks
This tool encompasses various metrics for evaluating wound characteristics, such as size, depth, and signs of infection. Interpretation of the results varies depending on the specific metrics used, but generally, a decrease in wound size and the absence of infection signs signify effective healing. Conversely, the presence of necrosis or an increase in wound size may indicate complications. Higher scores typically correlate with better healing outcomes, guiding clinicians in treatment decisions and monitoring progress.
Adverse Event Reporting Form
时间窗: Up to twelve weeks
This form is used to document any adverse reactions or events experienced by patients during treatment. The results are analyzed to calculate the incidence rate of adverse events, with lower rates suggesting that the treatment is safe and well-tolerated. Conversely, a higher frequency of adverse events may indicate safety concerns, prompting further investigation and potential modifications in treatment protocols. These findings are critical for evaluating the safety profile of interventions and informing clinical practice.
次要结局
- Hospital Anxiety and Depression Scale (HADS)(Up to twelve weeks)
- Pittsburgh Sleep Quality Index (PSQI)(Up to twelve weeks)
研究者
Agustín Aibar Almazán
Principal investigator
University of Jaén