A study to compare use of Feracrylum Gel with Cetrimide Cream on minor wounds
- Conditions
- Health Condition 1: null- â?¢Patients who have minor traumatic wounds such as cuts, abrasions, lacerations caused by road traffic accidents and other causesHealth Condition 2: T148- Other injury of unspecified body region
- Registration Number
- CTRI/2018/09/015825
- Lead Sponsor
- Themis Medicare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients who have minor traumatic wounds such as cuts, abrasions, lacerations caused by road traffic accidents and other causes
2. Patients who provide a signed informed consent to abide by the study requirements
1. Patients with life threatening injuries
2. Patients requiring wound suturing and hospitalization
3. Patients with pulse >100/min, Systolic BP < 90mm Hg or respiratory rate beyond 10-29/min
4. Patients with altered sensorium (Glasgow coma scale of <15)
5. Patients with severe bleeding or suspected internal hemorrhage
6. Patients with fractures
7. Patients with suspected internal injury to head, chest, abdomen, pelvis, spine or long bones
8. Patients with HIV, cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases
9. Pregnant and lactating women
10. Known hypersensitivity to any of the ingredients of the test / comparator formulation
11. Simultaneous participation in another clinical study
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Physicians Global Impression (PGI) Scale on wound condition at Visit 2 based on <br/ ><br>1. Discharge <br/ ><br>2. Local Edema <br/ ><br>3. Local TendernessTimepoint: Visit 2 (Day 2)
- Secondary Outcome Measures
Name Time Method 1. Change in the bacteriological flora on the wound at Visit 2 compared to Visit 1 <br/ ><br>2. PGI on wound condition at Visit 3 based on Discharge, Local Edema and Local Tenderness <br/ ><br>3. Ease of dressing change at Visit 2 and 3Timepoint: Day 2 and Day 7