Phase IV, Open-Label, 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
- Unknown
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 2. Local Edema
研究概览
简要总结
Objective: Tocompare the efficacy and safety of 1 % Feracrylum gel with 0.5% Cetrimide creamin preventing infection in patients with minor traumatic wound treated onoutpatient basis.
StudyDesign: Randomized, open-label, single-centre,comparative trial to study the efficacy and safety of Investigational MedicinalProduct (IMP) (1% Feracrylum Gel) and Reference Medicinal Product (RMP) (0.5%Cetrimide Cream) in patients with minor traumatic wound.
Adult patients of either genderwith minor traumatic wound, who as per the clinical judgment of the treatingphysician, do NOT require hospitalization and should be treated on outpatientbasis, will be screened for the study. After applying the inclusion andexclusion criteria, the qualifying patients will be randomized 1:1 to receiveeither IMP or RMP at the time of initial dressing and subsequently at eachdressing change.
Sample Size: Total 60 patients who willcomplete Visit 2 of the study
EfficacyParameters: Primary - Physician Global Impression (PGI) score on wound conditionat Visit 2 based on: 1) Discharge 2) Local Edema 3) Local Tenderness
Secondary– 1) Change in the bacteriological floraon the wound at Visit 2 compared to Visit 1 2) PGI on wound condition at Visit3 based on Discharge, Local Edema 3) Local Tenderness, Ease of dressing changeat Visit 2 and 3
Safetyparameters: 1) Vital parameters (Pulse rate, BP, respiratory and body temperature) willbe measured at the scheduled visits 2) Adverse event monitoring:Incidence and severity of any adverse event including allergic reactionsobserved 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 who have minor traumatic wounds such as cuts, abrasions, lacerations caused by road traffic accidents and other causes
- •Patients who provide a signed informed consent to abide by the study requirements.
排除标准
- •Patients with life threatening injuries
- •Patients requiring wound suturing and hospitalization
- •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 HIV, cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases
- •Pregnant and lactating women
- •Simultaneous participation in another clinical study.
结局指标
主要结局
2. Local Edema
时间窗: Visit 2 (Day 2)
3. Local Tenderness
时间窗: Visit 2 (Day 2)
Physicians Global Impression (PGI) Scale on wound condition at Visit 2 based on
时间窗: Visit 2 (Day 2)
1. Discharge
时间窗: Visit 2 (Day 2)
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)