A Prospective, Randomized, Controlled, Single-blind Clinical Investigation to Evaluate the Safety and Performance of ConnettivinaBio Plus Cream Compared to ConnettivinaBio Cream in the Management of Wounds in Patients at High Risk of Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- improving the wounds bed conditions in wounds at high risk of infection, after 14 days of treatment, compared to ConnettivinaBio cream
研究概览
简要总结
The clinical investigation plan will include a Screening/Baseline visit (V1) in which patients will be screened on the basis of inclusion/exclusion criteria and clinically evaluated. Screened and eligible patients will be randomly assigned in one of the two groups: Group 1 will receive ConnettivinaBio Plus cream whereas Group 2 will receive ConnettivinaBio cream. Lesions will be cleaned and a photo will be acquired with a digital camera.
In both groups, the schedule treatment will consist of daily medication changes.
Wound Bed Score, clinical signs of localized infection, measurement of the wound area, collection of the swab, according to the Levine's technique, EQ-5D questionnaire to the patient will be assessed on Day 1 (V1, baseline visit), 7 (V2), 14 (V3), 21 (V4) and 28 (V5) post-baseline. Treatments in both groups (ConnettivinaBio Plus or ConnettivinaBio) will be applied for a maximum period of 28 days. The easiness of treatment application will be also recorded at V5.
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)
盲法说明
At Screening/Baseline visit patients who signed the informed consent and are eligible for the study will be screened by the Investigator who will gather demographic and medical history data and perform the randomization procedure. After the allocation of the patient to Group 1 or 2, the Un-blinded Investigator will perform the treatment, according to the group allocation and instruct the patients on dressing daily renewal. The Investigator, who won't take part in the administration of study treatments and won't be aware on the patient.s group assignment, will perform all the evaluations for primary and secondary endpoint, during the visits (Blinded Evaluator).
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
- •Signed written informed consent.
- •Male or female ≥ 18 years
- •Having wounds (both chronic or acute wounds regardless of etiology), with the following characteristics:
- •Non infected
- •Wound Bed Score ≥4 and <13
- •Wound area ≤ 100 cm2
- •Patient having one or more factors associated with increased risk of wound infection (IWII, 2016)
- •Patient able to read and understand the language and content of the study material, understand the requirements for follow-up visits, is willing to provide information at the scheduled evaluations and is willing, able and ensuring to comply with the study requirements for the whole study period.
排除标准
- •Absence of factors associated with increased risk of wound infection
- •Infected wounds - where infection is defined by:
- •For chronic wounds:
- •A combination of three or more signs or symptoms of local infection: periwound skin erythema, local heat, persistent pain, oedema of wound.s edge, malodour, pus and heavy exudation (Cutting KF, 1994; Trial C, 2010);
- •For acute wounds:
- •Cellulitis or pus or abscess, Delayed healing, erythema, hardening of edge, serous-purulent drainage, malodour
- •Non-vital tissue greater than 25% of the total wound area
- •Heavily exuding wounds
- •Presence of fistula
- •History of connective tissue disease, e.g., systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome or mixed connective tissue disease
- •Active malignant disease
- •Active sickle cell disease
- •radiation therapy
- •Known allergy to any of the devices' constituents
- •Pregnant and breastfeeding women
- •Subjects unable to understand informed consent or having a high probability of non- compliance with the study procedures and or non-completion of the study according to investigator's judgement.
结局指标
主要结局
improving the wounds bed conditions in wounds at high risk of infection, after 14 days of treatment, compared to ConnettivinaBio cream
时间窗: at day 14
The amelioration of wound's bed conditions will be evaluated by measuring the proportion of patients having an increase of at least one subclass of the Wound Bed Score (WBS) (0-16 score; 0 worse score-16 best score possible) (Falanga V, 2006) from baseline to 14 days of treatment with ConnettivinaBio Plus cream compared to ConnettivinaBio cream.
次要结局
- improving the wound bed condition(At days 7, 14, 21 and 28)
- control of bacterial load of wounds(At days 7, 14, 21 and 28)
- control on signs of wound infection(At days 7, 14, 21 and 28)
- improving the reepithelization rate(At days 7, 21 and 28)
- improving patient's quality of life(At days 7, 14, 21 and 28)
- clinician's global assessment of the lesion(At days 7, 14, 21 and 28)
- easiness of the treatment application(at day 28)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](throughout study completion, an average of 1 year)