| CTRI Number |
CTRI/2011/09/002030 [Registered on: 30/09/2011] Trial Registered Prospectively |
| Last Modified On: |
16/05/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study of Silver sulfadiazine cream (nanonized)and Silverex cream in burns wounds |
|
Scientific Title of Study
|
Comparative Efficacy, Safety and Tolerability of Silver Sulfadiazine Cream (Nanonized) and Silverex Cream in the Prophylaxis of Infection in Burn Wounds - An Open-label, Randomized, Pilot Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RSILVE102013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MONIKA ABBI |
| Designation |
Research Scientist |
| Affiliation |
|
| Address |
Research Scientist, Medical Affairs and Clinical Research, Ranbaxy Research Laboratories, Ltd
Gurgaon
HARYANA
122015
India |
| Phone |
01244194218 |
| Fax |
|
| Email |
monika.abbi@ranbaxy.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shradhanand Singh |
| Designation |
Senior Research Scientist |
| Affiliation |
|
| Address |
Senior Research Scientist, Medical Affairs and Clinical Research, Ranbaxy Research Laboratories, Ltd
Plot No.77-B, Sector-18, IFFCO Road,
Udyog Vihar Industrial Area
Gurgaon
HARYANA
122015
India |
| Phone |
|
| Fax |
|
| Email |
Shradhanand.singh@ranbaxy.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shradhanand Singh |
| Designation |
Senior Research Scientist |
| Affiliation |
|
| Address |
Medical Affairs and Clinical Research, Ranbaxy Research Laboratories, Ltd
Plot No.77-B, Sector-18, IFFCO Road,
Udyog Vihar Industrial Area
HARYANA
122015
India |
| Phone |
|
| Fax |
|
| Email |
Shradhanand.singh@ranbaxy.com |
|
|
Source of Monetary or Material Support
|
| Ranbaxy Laboratories Ltd
Medical Affairs & Clinical Research, Plot No.77-B, Sector-18, IFFCO Road, Udyog Vihar Industrial Area, Gurgaon |
|
|
Primary Sponsor
|
| Name |
Ranbaxy Laboratories Ltd |
| Address |
Medical Affairs & Clinical Research, Plot No.77-B, Sector-18, IFFCO Road, Udyog Vihar Industrial Area, Gurgaon |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakesh Jindal |
Balaji Burns & Plastic Centre |
Balaji Burns & Plastic Centre
Near Church, Mall Road
Karnal
Karnal
HARYANA |
9812052697
riaamish@yahoo.com |
| Dr Ashok Gupta |
Clinic |
236, Civil street,
Adjoining Bengali Sweets Corner
Ghumar Mandi
Ludhiana
Ludhiana
PUNJAB |
9815500847
docashish2001@gmail.com |
| Dr Sanjeev Uppal |
Dayanand Medical College |
Department of Plastic Surgery
Dayanand Medical College
Ludhiana
Ludhiana
PUNJAB |
09814024125
docashish2001@gmail.com |
| Dr L K Makhija |
Dr Ram Manohar Lohia Hospital, |
Senior Plastic Surgeon & Head
Dr Ram Manohar Lohia Hospital
Baba Kharak Singh Marg
New Delhi-110001
Central
DELHI |
9312400091
lalitmakhija@yahoo.com |
| Dr Prashant Tyagi |
Saxena Multispeciality Hospital Pvt Ltd |
Saxena Multispeciality Hospital Pvt Ltd
112-113, T.P Scheme,
Delhi road
Sonepat-131001
Sonipat
HARYANA |
09416015789
dhruvprashant@hotmail.com |
| Dr RP Narayan |
VM Medical College & Safdarjung Hospital |
Dept of Burns & Plastic Surgery,
VM Medical College & Safdarjung Hospital
New Delhi-110016
South
DELHI |
011-26109078
drrpnarayan@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Biomedical Ethics Committee, New Delhi |
Approved |
| Dr RML Hospital Ethics Committee, Dr RML Hospital, New Delhi |
Approved |
| Drug Trial Ethics Committee, Dayanand Medical College, Ludhiana |
Approved |
| VM Medical College & Safdarjung Hospital Ethics Committee, Safdarjung Hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Burns, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Silver Sulfadiazine 0.5% and Silver Sulfadiazine 0.75% |
The cream will be applied once daily in case of closed dressing and twice daily in case of open dressing. A thin layer of study medication sufficient to cover the burn wound will be applied. Treatment with the study medication will be continued until the wound heals or upto a period of 21 days, whichever is earlier |
| Comparator Agent |
Silver Sulfadiazine Cream 1% |
The cream will be applied once daily in case of closed dressing and twice daily in case of open dressing. A thin layer of study medication sufficient to cover the burn wound will be applied. Treatment with the study medication will be continued until the wound heals or upto a period of 21 days, whichever is earlier |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who have given written informed consent to participate in the study.
2. Subjects of either sex aged between 18 and 65 years (both inclusive) with partial thickness burns of thermal origin covering 10% of the TBSA and suitable for outpatient management.
3. Subjects in whom burn injury is 24 hours old at the time of screening.
4. Subjects with clean, non-infected wound as judged by the investigator.Presence of infection will be judged clinically by symptoms and signs that include purulent drainage, erythema, warmth, exudation, malodor, pain and/or fever.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with history of hypersensitivity to silver sulfadiazine, other sulfonamides, chlorhexidine or any of the excipients of study formulations#.
2.Subjects with burn wounds associated with chemical, electrical or inhalational injury.
3.Subjects with full thickness burns (a burn involving destruction of the entire epidermis and dermis, leaving no residual epidermal cells to repopulate) or circumferential burns (a burn which encircles an entire body part) or superficial burn (a burn which remains confined to the epidermis).
4.Subjects with burns involving genitalia, head (including face), perineum or major joints.
5.Subjects with burns of hands or feet likely to cause functional impairment.
6.Subjects with burn wounds not expected to heal within 21 days or requiring systemic antimicrobial treatment or surgical intervention (except surgical debridement) during the study.
7.Subjects with burn wounds expected to heal in less than 7 days.
8.Subjects with burns and concomitant trauma (such as fractures) in which the burn injury poses the greatest risk of morbidity and mortality.
9.Burn injury in subjects with preexisting medical disorders (e.g., diabetes mellitus, cancer or other immunocompromising conditions) that could complicate management, prolong recovery, or affect mortality.
10.Subjects who are under treatment with topical or systemic steroid medications or immunosuppressive agents.
11.Subjects with significant disease(s) or disorder(s) other than burn injury that in the opinion of the investigator may (i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or (iii) cause concern regarding subject’s ability to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects with wound infection during the study treatment period |
from day 1 to day 21 i.e during the study treatment period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of subject achieving complete wound closure |
Day 14, 7 & 21 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/10/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, open-label, comparative, pilot study. Objective of this study is to collect data for selection of a suitable strength of silver sulfadiazine cream (Nanonized) for future pivotal study.
After screening, eligible patients will be randomized to one of the three topical antimicrobial treatment groups i.e, Silver sulfadiazine cream nanonized (0.5%), Silver sulfadiazine cream nanonized (0.75%) & Silverex cream 1%. The cream will be applied once daily in case of closed dressings & twice daily in case of open dressings.
Treatment with study medication will be continued until the wound(s) heal or upto day 21, whichever is earlier. All subjects will be called for a safety followup assessment on day 42.
Study will be initiated only after obtaining regulatory approval & EC approval from respective sites. |