A study to compare the effectiveness of Feracrylum Gel and Cetrimide Cream on minor wounds
- Conditions
- Health Condition 1: null- Patients who have minor traumatic wounds such as cuts, abrasions, lacerations caused by road traffic accidents and other causes
- Registration Number
- CTRI/2018/07/014753
- Lead Sponsor
- Themis Medicare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients of either sex in the age group between 18 to 60 years
2. Patients who have minor traumatic wounds such as cuts, abrasions, lacerations caused by road traffic accidents and other causes
3. Patients with fresh/untreated wound
4. Patients who provide a signed informed consent to abide by the study requirements
1. Patients with life threatening injuries
2. Patients with any wound requiring hospitalization
3. Patients with bruises
4. Patients with wounds deeper than subcutaneous tissue
5. Patients with wounds caused by animal bites and burns
6. Patients with pulse > 100/min, Systolic BP < 90mm Hg or Respiratory Rate beyond 10-29/min
7. Patients with altered sensorium (Glasgow coma scale of < 15)
8. Patients with severe bleeding or suspected internal hemorrhage
9. Patients with fractures
10. Patients with suspected internal injury to head, chest, abdomen, pelvis, spine or long bones
11. Patients with history of HIV, cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases
12. Women who are lactating or with known pregnancy at the time of screening
13. Known hypersensitivity to any of the ingredients of the test / comparator formulation
14. Simultaneous participation in another clinical study
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Physician Global Impression (PGI) score on wound condition at Visit 2 (Day 3) based on: <br/ ><br>1. Discharge <br/ ><br>2. Local Edema <br/ ><br>3. Local TendernessTimepoint: Visit 2 (Day 3)
- 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: Visit 1 (Day 0), Visit 2 (Day 3), Visit 3 (Day 7 ±1)