A study to compare use of Feracrylum Gel with Cetrimide Cream on minor wounds

Phase IV, Open-Label, Randomized, Parallel-Group, Comparative Study of Feracrylum Gel and Cetrimide Cream on Minor Traumatic Wounds in Non-Hospitalized Patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2018/09/015825

Enrollment

Registered

2018-09-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- â?¢ Patients who have minor traumatic wounds such as cuts, abrasions, lacerations caused by road traffic accidents and other causes Health Condition 2: T148- Other injury of unspecified body region

Interventions

Intervention1: Feracrylum gel (1%): Feracrylum 1% Gel manufactured by Themis Medicare Limited to be used for 7 days Control Intervention1: Cetrimide Cream (0.5%): Cetrimide Cream (0.5%) - Topical crea

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 1. Patients with life threatening injuries 2. Patients requiring wound suturing and hospitalization 3. Patients with pulse >100/min, Systolic BP 4. Patients with altered sensorium (Glasgow coma scale of 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

Design outcomes

Primary

Measure	Time frame
Physicians Global Impression (PGI) Scale on wound condition at Visit 2 based on 1. Discharge 2. Local Edema 3. Local TendernessTimepoint: Visit 2 (Day 2)	—

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: Day 2 and Day 7	—

Countries

India

Contacts

Public ContactDr Ashok Swain

Themis Medicare Limited

ashok.swain@themismedicare.com09160255553

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026