Treatment of Infected Surgical Wounds With Negative Pressure Topical Therapy and Instillation (With or Without Antiseptic) Versus no Instillation
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Absence of clinical infection (according NHSN 2014)
研究概览
简要总结
The objective of this study is to evaluate the effectiveness of PTNi therapy versus PTN therapy without instillation in the treatment of infected surgical wounds. Investigators mean to verify differences of effectiveness between the different types of instilled substances, normal saline versus Amukine Med 0.5%.
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
- None
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
- •Patients with infected surgical wounds.
- •Patient age greater than or equal to 18 years.
- •Patients who have given informed consent to the enrollment in the trial and to the processing of personal data.
排除标准
- •Patients unable of consent.
- •Patients affected by serious medical conditions that, according to the investigator's opinion, represent a contraindication to the study participation.
- •Patients affected by wounds with exposition of blood vessels, sutures, organs or nerves and open wounds in mediastinum or abdomen.
- •Patients with malignancy at the wound.
- •Patients with untreated osteomyelitis.
- •Patients with enteric and unexplored fistulas.
- •Patients with necrotic tissue and eschar.
- •Immunocompromised patients or in treatment with corticosteroids.
- •Suspected or known allergic diathesis to the product of medication.
- •Patients with coagulation disease.
研究组 & 干预措施
PTNiA
Topical negative pressure therapy with instillation of saline solution (6 times daily).
During the instillation of saline solution, aspiration is stopped for 10-15 minutes and subsequently the device is programmed to exert a sub atmospheric pressure in aspiration of at least 50 mmHg up to a maximum of 200 mmHg.
The change of dressing is carried out on the first day after the application of the device, and thereafter, as needed (approximately every 3 or 4 days).
干预措施: PTNiA (Device)
PTNiB
Topical negative pressure therapy with instillation of Amukine Med 0,05% (6 times daily).
During the instillation of Amukine Med 0,05%, aspiration is stopped for 10-15 minutes and subsequently the device is programmed to exert a sub atmospheric pressure in aspiration of at least 50 mmHg up to a maximum of 200 mmHg.
The change of dressing is carried out on the first day after the application of the device, and thereafter, as needed (approximately every 3 or 4 days).
干预措施: PTNiB (Device)
PTN
Topical negative pressure therapy (without instillation). The device is programmed to exert a sub atmospheric pressure in aspiration of at least 50 mmHg up to a maximum of 200 mmHg.
The change of dressing is carried out on the first day after the application of the device, and thereafter, as needed (approximately every 3 or 4 days).
干预措施: PTN (Device)
结局指标
主要结局
Absence of clinical infection (according NHSN 2014)
时间窗: 1 month
frequency of wound without clinical infection
Absence of clinical infection
时间窗: 1 month
number of days to absence clinical infection
次要结局
- Treatment days(1 month)
- Wound closure(1 month)
- Patient's discharge(participants will be followed for the duration of hospital stay, an expected average of 5 weeks)
- Patient's pain (Numeric Rating Scale (NRS)(1 month)
研究者
Gabrielli Barbara
Physician
Associazione Infermieristica per lo studio delle Lesioni Cutanee