A prospective, single-arm study to assess the effectiveness and safety of Theruptor Novo dressing pad in the treatment of chronic lower extremity wounds
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 49
- 试验地点
- 3
- 主要终点
- The percentage of wound contraction as calculated by using the initial and final area every week for 8 weeks by using graded sterile centimeter ruler sterile scale
研究概览
简要总结
Wound healing is a complex sequence of events that begins with injury and ends with successful closure. Wound healing process consists of a highly integrated and overlapping phases that is critical in maintaining the normal function of skin. Wound treatment is different in everybody and often depends on the number of factors. Age, skin type, type of wound, location, and severity are some of the factors which depends on treating wound and avoiding infection.
With many disease processes, the cascade of events involved in wound healing can be affected, resulting in chronic, non-healing wounds. All wounds have the potential to become chronic wounds. Understanding and addressing the challenges in the treatment of chronic wounds will lead to a better clinical outcome (faster and more durable wound closure), and avoid inappropriate treatment that may cause deterioration of the wound, delay wound healing, or harm the patient, resulting in improved patient quality of life and reduced healthcare costs.
The ideal dressing should keep the wound moist but not macerated, limit bacterial overgrowth, keep odour to a minimum, and be comfortable to wear. Important criteria to consider before choosing a specific wound dressing are cleaning, absorbing, regulating, and the need to add medication. It is important that the dressings be removed atraumatically, to avoid further damage to the wound surface during dressing changes
Theruptor Novo is a sterile barrier wound dressing intended for use as a primary dressing for exuding wounds, first and second degree burns, minor wounds and surgical wounds; to secure and prevent movement of a primary dressing; and as a wound packing. It is a 3D hydrocellular structure (moisture management) dressing pad, which is made of Polyethylene terephthalate, polyurethane and Dimethyl Tetradecyl [3(trimethoxysily) propyl] ammonium chloride (DTAC) for antimicrobial action.
· This study is done to assess the efficacy and safety of Theruptor Novo dressing pad in patients with chroniclower extremity wound
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients aged above 18 years with ≤ 3 wounds in the lower extremity considered for the study
- •Patient with a low to moderate exuding lower extremity wound with size ≤ 8 cm × 8 cm, with less than 50% of contraction in the past 4 weeks even after standard treatment
- •Patient willing to give written informed consent and adhere to study procedures.
排除标准
- •Patients with wounds caused by venous or arterial insufficiency, or electrical or chemical burns
- •Patients with wounds showing presence of necrosis, purulence or sinus tracts that cannot be removed by debridement
- •Patients with history of active Charcoat’s foot of the study foot within 6 months of screening
- •Patients with progressive weight loss
- •Patients undergoing treatment with corticosteroids, immunosuppressive or chemotherapeutic agents, or radiotherapy
- •Patients with history of other diseases, which can alter the normal healing of the wound such as connective tissue disease, renal failure, liver failure, and malignancy
- •Patients who underwent revascularization surgery in the last 8 weeks
- •Patients with ankle-brachial index(ABI) < 0.7
- •Pregnant or lactating mothers.
结局指标
主要结局
The percentage of wound contraction as calculated by using the initial and final area every week for 8 weeks by using graded sterile centimeter ruler sterile scale
时间窗: Day 7, 14, 21, 28, 35, 42, 49 & 56
次要结局
- Wound dimensions, wound edge, type of tissue in the wound bed, the depth of the wound, exudate of the wound, Peri-wound skin and presence of infection/inflammation will be assessed by using RESVECH 2.0 scale(Day 1, 7, 14, 21, 28, 35, 42, 49 & 56)
- Visual analogue scale (VAS) is used to assess pain every week during dressing pad removal(Day 7, 14, 21, 28, 35, 42, 49 & 56)
- Subject satisfaction of wound healing using 5-point scale(Day 7, 14, 21, 28, 35, 42, 49 & 56)
- Wound360 version 1.1 application is used for wound characterization and photography(Day 1, 7, 14, 21, 28, 35, 42, 49 & 56)
- To assess adverse events(Day 7, 14, 21, 28, 35, 42, 49 & 56)