| 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
|
|
|
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
|
|
|
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 |