Clincal Evaluation of the Effectiveness and Tolerability of Fitostimoline Plus Cream and Fitostimoline Plus Gauze vs Connettivina Bio Plus Cream and Connettivina Bio Plus Gauze in the Treatment of Acute Skin Lesions
试验速览
- 阶段
- 不适用
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Total symptom score
研究概览
简要总结
This study aims to compare the efficacy and clinical tolerability of two medical devices in gauze and cream containing the aqueous extract of triticum vulgare and polyhexanide in comparison with two medical devices containing hyaluronic acid and silver sulfadiazine in the treatment of acute skin lesions . The reason why the two types of devices are compared is because hyaluronic acid and silver sulfadiazine represent the gold standard for the treatment of acute skin lesions. Therefore, making a comparison between the activity of the aqueous extract of triticum vulgare and polyhexanide and this gold standard of control in the treatment of acute skin lesions, is useful to better define the efficacy and tolerability of both medical devices in order to eventually expand the therapeutic armamentarium available for the treatment of acute skin lesions
详细描述
Skin lesions, more or less deep, are areas of rupture and tissue loss with exposure of the underlying tissues.
The term "external lesion" or "wound" indicates the morphological and functional destruction of the continuity of the superficial skin layers and, in the most serious cases, of the deep subcutaneous layers.
The lesions are evaluated and cataloged on the basis of their width, depth and characteristics. Furthermore, the development, the causes (etiopathogenesis) and the pathophysiological context of the wound are considered.
Superficial, slight lesions affect only the epidermis, the dermis and at most part of the hypodermis; the deeper ones involve all the subcutaneous tissue (fat) up to the muscles, the periosteum, reaching the exposure of the bone or supporting structures (tendons and cartilages); the most severe (chronic) are characterized by loss of substance in the skin and a poor tendency to healing.
According to the timing of healing, the lesions are divided into acute and chronic.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Outpatient patients (regardless of sex) aged 18 and over;
- •Presence of acute injury
- •Willingness to cooperate and ability to understand the procedures and purposes of the study;
- •Willingness to take part in the study and to adhere to the experimental procedures certified by signing the written informed consent
排除标准
- •Pregnancy or breastfeeding;
- •Inadequate contraceptive procedures in fertile women;
- •Anamnestic data of any local and / or systemic pathology potentially able to interfere with the study parameters;
- •Chronic concomitant treatment with local antiseptics, anti-inflammatory drugs (steroid and non-steroidal), analgesic, antineoplastic, immunosuppressive drugs;
- •Immunodeficiency states (eg HIV infection); neoplastic diseases in progress;
- •Non-therapeutic use of psychoactive substances;
- •Abuse of drugs and / or alcohol;
- •Neurological disorders or psychiatric conditions that may affect the validity of the consent and / or compromise the patient's adherence to the study procedures;
- •Allergy, hypersensitivity or intolerance known to the constituents of the preparations under study;
- •Any condition, medical or otherwise, that could significantly reduce the possibility of obtaining reliable data, achieve the objectives of the study, refine the completion of this;
- •Presumption of poor reliability or collaboration;
- •Treatment with any investigational drug in the last 30 days prior to the start of the study;
- •Patients already enrolled in this study;
- •Center staff directly involved in the management of the study and close relatives of that.
结局指标
主要结局
Total symptom score
时间窗: 46 days
Total symptom score will be measured by a scale from 0 (absence of symptoms) to 4 (maximum intensity of symptoms).
次要结局
- Visual Analog Scale(46 days)
研究者
carmine alfano
PROFESSOR
Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona