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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 24 November 2021
Main ID: CTRI/2018/09/015825

Date of registration: 25-09-2018

Prospective Registration: Yes

Primary sponsor: Themis Medicare Limited
Public title: A study to compare use of Feracrylum Gel with Cetrimide Cream on minor wounds
Scientific title: Phase IV, Open-Label, Randomized, Parallel-Group, Comparative Study of Feracrylum Gel and Cetrimide Cream on Minor Traumatic Wounds in Non-Hospitalized Patients
Date of first enrolment: 01-10-2018
Target sample size: 60

Recruitment status: Not Yet Recruiting

URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=25957
Study type: PMS
Randomized, Parallel Group Trial
Study design:
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
Phase: Post Marketing Surveillance
Countries of recruitment
India
Contacts
Name: Dr Ashok Swain Name: Dr Ashok Swain
Address: Medical Affairs, Themis Medicare Limited,11/12 Udyog Nagar, Goregaon (West), Mumbai 400104 Mumbai (Suburban), MAHARASHTRA India Address: Medical Affairs, Themis Medicare Limited, 11/12 Udyog Nagar, Goregaon (West), Mumbai 400104 Mumbai (Suburban), MAHARASHTRA India
Telephone: 09160255553 Telephone: 09160255553
Email: ashok.swain@themismedicare.com Email: ashok.swain@themismedicare.com
Affiliation: Themis Medicare Limited Affiliation: Themis Medicare Limited
Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
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
Intervention(s)
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 cream to be used for 7 days
Primary Outcome(s)
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 Outcome(s)
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

Secondary ID(s)
TML-Fera-2018-02-version 01-dt 23 Apr 2018
Source(s) of Monetary Support
Themis Medicare Limited,11/12 Udyog Nagar, Goregaon (West), Mumbai - 400104
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 17/09/2018
Contact:
SMS Medical College and Attached Hospital
Results
Results available:
Date Posted:
Date Completed:
URL:

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