| CTRI Number |
CTRI/2018/07/014753 [Registered on: 05/07/2018] Trial Registered Prospectively |
| Last Modified On: |
15/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the effectiveness of Feracrylum Gel and Cetrimide Cream on minor wounds |
|
Scientific Title of Study
|
Phase IV, Multicentre, Observer-Blind, 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-2018-03 version 1.1 dated 25 May 2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chetan V Kantharia |
| Designation |
Head of Department of Surgical Gastroenterology |
| Affiliation |
King Edward Memorial Hospital |
| Address |
Department of Surgical Gastroenterology
KEM Hospital
Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09869072625 |
| Fax |
|
| Email |
kanthariachetan@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 = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chetan V Kantharia |
King Edward Memorial Hospital |
Department of Surgical Gastroenterology
KEM Hospital,
Parel, Mumbai- 400012.
Mumbai
MAHARASHTRA |
09869072625
kanthariachetan@gmail.com |
| Dr Smruti Ghetla |
RN Cooper Hospital |
Department of General Surgery,
RN Cooper Hospital,
Juhu, Mumbai- 400056
Mumbai (Suburban)
MAHARASHTRA |
9820280058
smruti.ghetla@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Intersystem Biomedica Ethics Committee |
Approved |
| Intersystem Biomedica Ethics Committee |
Approved |
| Intersystem Biomedica Ethics Committee |
Approved |
| Intersystem Biomedica Ethics Committee |
Approved |
| Intersystem Biomedica Ethics Committee |
Approved |
| Nanavati Ethics Committee |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cetrimide Cream (0.5%) |
The route of administration for Cetrimide Cream (0.5%) is topical.
A thin layer of Cetrimide cream will be applied over entire wound area during initial and subsequent dressing change. If the wound is open, Cetrimide will be applied twice daily.
Total duration of treatment is 7 days. |
| Intervention |
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 dressing change. If the wound is open, Feracrylum will be applied twice daily.
Total duration of treatment is 7 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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 < 90mm Hg or Respiratory Rate beyond 10-29/min
7. Patients with altered sensorium (Glasgow coma scale of < 15)
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 |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Physician Global Impression (PGI) score on wound condition at Visit 2 (Day 3) based on:
1. Discharge
2. Local Edema
3. Local Tenderness |
Visit 2 (Day 3) |
|
|
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 |
Visit 1 (Day 0), Visit 2 (Day 3), Visit 3 (Day 7 ±1) |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
09/07/2018 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study 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, multicentre, observer-blind, comparative trial to study the efficacy and safety of Investigational Medicinal Product (IMP) and Reference Medicinal Product (RMP) 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, and Local Tenderness 3) Ease of dressing change at Visit 2 and 3Safety 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. Assessment Schedule: There will be 3 visits: Visit 1 (Day 0), Visit 2 (Day 3), Visit 3 (Day 7 ±1). Efficacy parameters: Visit 1, Visit 2 and Visit 31. Safety parameters: Vital parameters will be recorded on Visit 1, Visit 2 and Visit 3 Adverse event monitoring: Any adverse event observed during the study will be monitored and recorded in CRF
|