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CTRI Number  CTRI/2018/09/015825 [Registered on: 25/09/2018] Trial Registered Prospectively
Last Modified On: 24/09/2018
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare use of Feracrylum Gel with Cetrimide Cream on minor wounds 
Scientific Title of Study   Phase IV, Open-Label, Randomized, Parallel-Group, Comparative Study of Feracrylum Gel and Cetrimide Cream on Minor Traumatic Wounds in Non-Hospitalized Patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
TML-Fera-2018-02-version 01-dt 23 Apr 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lakshman Agarwal 
Designation  Professor of Surgery 
Affiliation  SMS Medical College and Hospital 
Address  Department of Surgery, SMS Medical College and Hospital, Jaipur, Rajastan

Jaipur
RAJASTHAN
302004
India 
Phone  09828023777  
Fax    
Email  lakshmansumita@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashok Swain 
Designation  General Manager 
Affiliation  Themis Medicare Limited 
Address  Medical Affairs, Themis Medicare Limited, 11/12 Udyog Nagar, Goregaon (West), Mumbai

Mumbai (Suburban)
MAHARASHTRA
400104
India 
Phone  09160255553  
Fax    
Email  ashok.swain@themismedicare.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashok Swain 
Designation  General Manager 
Affiliation  Themis Medicare Limited 
Address  Medical Affairs, Themis Medicare Limited,11/12 Udyog Nagar, Goregaon (West), Mumbai

Mumbai (Suburban)
MAHARASHTRA
400104
India 
Phone  09160255553  
Fax    
Email  ashok.swain@themismedicare.com  
 
Source of Monetary or Material Support  
Themis Medicare Limited,11/12 Udyog Nagar, Goregaon (West), Mumbai - 400104 
 
Primary Sponsor  
Name  Themis Medicare Limited 
Address  11/12 Udyog Nagar, Goregaon (West), Mumbai - 400104 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Lakshman Agarwal  SMS Medical College and Hospital  Department of Surgery, SMS Medical College and Hospital, Jaipur, Rajasthan - 302004
Jaipur
RAJASTHAN 
09828023777

lakshmansumita@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMS Medical College and Attached Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  • Patients who have minor traumatic wounds such as cuts, abrasions, lacerations caused by road traffic accidents and other causes , (1) ICD-10 Condition: T148||Other injury of unspecified body region,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cetrimide Cream (0.5%)  Cetrimide Cream (0.5%) - Topical cream to be used for 7 days 
Intervention  Feracrylum gel (1%)  Feracrylum 1% Gel manufactured by Themis Medicare Limited to be used for 7 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Physicians Global Impression (PGI) Scale on wound condition at Visit 2 based on
1. Discharge
2. Local Edema
3. Local Tenderness 
Visit 2 (Day 2) 
 
Secondary Outcome  
Outcome  TimePoints 
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 3 
Day 2 and Day 7 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/10/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Objective: To compare the efficacy and safety of 1 % Feracrylum gel with 0.5% Cetrimide cream in preventing infection in patients with minor traumatic wound treated on outpatient basis.

Study Design: Randomized, open-label, single-centre, comparative trial to study the efficacy and safety of Investigational Medicinal Product (IMP) (1% Feracrylum Gel) and Reference Medicinal Product (RMP) (0.5% Cetrimide Cream) in patients with minor traumatic wound.

Adult patients of either gender with minor traumatic wound, who as per the clinical judgment of the treating physician, do NOT require hospitalization and should be treated on outpatient basis, will be screened for the study. After applying the inclusion and exclusion criteria, the qualifying patients will be randomized 1:1 to receive either IMP or RMP at the time of initial dressing and subsequently at each dressing change.

Sample Size: Total 60 patients who will complete Visit 2 of the study

Efficacy Parameters: Primary - Physician Global Impression (PGI) score on wound condition at Visit 2 based on: 1) Discharge 2) Local Edema 3) Local Tenderness

Secondary – 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 3) Local Tenderness, Ease of dressing change at Visit 2 and 3

Safety parameters: 1) Vital parameters (Pulse rate, BP, respiratory and body temperature) will be measured at the scheduled visits 2) Adverse event monitoring: Incidence and severity of any adverse event including allergic reactions observed during the study will be monitored and recorded in CRF

 
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