Health Condition 1: null- Patients who have minor traumatic wounds such as cuts, abrasions, lacerations caused by road traffic accidents and other causes
Conditions
Interventions
Intervention1: Feracrylum gel (1%): The route of administration for Feracrylum 1% Gel is topical.
A thin layer of Feracrylum will be applied over entire wound area during initial and subsequent dressi
Sponsors
Themis Medicare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 7. Patients with altered sensorium (Glasgow coma scale of 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physician Global Impression (PGI) score on wound condition at Visit 2 (Day 3) based on: 1. Discharge 2. Local Edema 3. Local TendernessTimepoint: Visit 2 (Day 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 3Timepoint: Visit 1 (Day 0), Visit 2 (Day 3), Visit 3 (Day 7 ±1) | — |
Countries
India
Contacts
Public ContactDr Ashok Swain
Themis Medicare Limited
Outcome results
None listed