Phase IV, Multicentre, Observer-Blind, Randomized, Parallel-Group, Comparative Study of Feracrylum Gel and Cetrimide Cream on Minor Traumatic Wounds in Non-Hospitalized Patients
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Physician Global Impression (PGI) score on wound condition at Visit 2 (Day 3) based on:
研究概览
简要总结
Study Objective: To compare the efficacy and safety of 1 % Feracrylum gel with 0.5% Cetrimide cream in preventing infection in patients with minor traumatic wound treated on outpatient basis
Study Design: Randomized, multicentre, observer-blind, comparative trial to study the efficacy and safety of Investigational Medicinal Product (IMP) and Reference Medicinal Product (RMP) in patients with minor traumatic wound. Adult patients of either gender with minor traumatic wound, who as per the clinical judgment of the treating physician, do NOT require hospitalization and should be treated on outpatient basis, will be screened for the study. After applying the inclusion and exclusion criteria, the qualifying patients will be randomized 1:1 to receive either IMP or RMP at the time of initial dressing and subsequently at each dressing change.
Sample Size: Total 60 patients who will complete Visit 2 of the study
Efficacy Parameters: **Primary -**Physician Global Impression (PGI) score on wound condition at Visit 2 based on:
1) Discharge 2) Local Edema 3) Local Tenderness
Secondary -
1) Change in the bacteriological flora on the wound at Visit 2 compared to Visit 1
2) PGI on wound condition at Visit 3 based on Discharge, Local Edema, and Local Tenderness
3) Ease of dressing change at Visit 2 and 3
**Safety parameters:**1. Vital parameters (Pulse rate, BP, respiratory and body temperature) will be measured at the scheduled visits. 2. Adverse event monitoring: Incidence and severity of any adverse event including allergic reactions observed during the study will be monitored and recorded in CRF.
**Assessment Schedule:**There will be 3 visits: Visit 1 (Day 0), Visit 2 (Day 3), Visit 3 (Day 7 ±1).
Efficacy parameters: Visit 1, Visit 2 and Visit 31. Safety parameters: Vital parameters will be recorded on Visit 1, Visit 2 and Visit 3
Adverse event monitoring: Any adverse event observed during the study will be monitored and recorded in CRF
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex in the age group between 18 to 60 years
- •Patients who have minor traumatic wounds such as cuts, abrasions, lacerations caused by road traffic accidents and other causes
- •Patients with fresh/untreated wound
- •Patients who provide a signed informed consent to abide by the study requirements.
排除标准
- •Patients with life threatening injuries
- •Patients with any wound requiring hospitalization
- •Patients with bruises
- •Patients with wounds deeper than subcutaneous tissue
- •Patients with wounds caused by animal bites and burns
- •Patients with pulse > 100/min, Systolic BP < 90mm Hg or Respiratory Rate beyond 10-29/min
- •Patients with altered sensorium (Glasgow coma scale of < 15)
- •Patients with severe bleeding or suspected internal hemorrhage
- •Patients with fractures
- •Patients with suspected internal injury to head, chest, abdomen, pelvis, spine or long bones
- •Patients with history of HIV, cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases
- •Women who are lactating or with known pregnancy at the time of screening
- •Known hypersensitivity to any of the ingredients of the test / comparator formulation
- •Simultaneous participation in another clinical study.
结局指标
主要结局
Physician Global Impression (PGI) score on wound condition at Visit 2 (Day 3) based on:
时间窗: Visit 2 (Day 3)
1. Discharge
时间窗: Visit 2 (Day 3)
2. Local Edema
时间窗: Visit 2 (Day 3)
3. Local Tenderness
时间窗: Visit 2 (Day 3)
次要结局
- 1. Change in the bacteriological flora on the wound at Visit 2 compared to Visit 1(2. PGI on wound condition at Visit 3 based on Discharge, Local Edema, and Local Tenderness)