CTRI/2014/11/005188 [Registered on: 07/11/2014] Trial Registered Prospectively
Last Modified On:
13/12/2016
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Nanonized Silver Sulfadiazine Cream in prevention of Infections in Burn wounds
Scientific Title of Study
Comparative Efficacy, Safety and Tolerability of Silver Sulfadiazine Cream (Nanonized) 0.5% w/w and Silverex Cream 1% w/w in the Prophylaxis of Infection in Burn Wounds – A Double-Blind, Randomized, Pivotal Study
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
R2012003 Version 2 dated 13.09.2013
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Monika Obrah
Designation
Project Leader
Affiliation
Sun Pharmaceutical Industries Ltd
Address
Medical Affairs and Clinical Research,
Sun Pharmaceutical Industries Ltd
Plot No.77-B, Sector-18, IFFCO Road,
Udyog Vihar Industrial Area
Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital
Department of General Surgery, Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital, Srikakulam-532001, Andhra Pradesh Srikakulam ANDHRA PRADESH
09849702720
rimsresearch@gmail.com
Dr RK Kajla
S.P. Medical College
Department of Surgery
S.P. Medical College & AG Hospitals, Bikaner-334003, Rajasthan Bikaner RAJASTHAN
Department of Plastic Surgery, Siddhartha Medical College, NH5 Frontage Rd, Opp. Varun Maruthi Showroom, Near Health University, Gunadala, Vijayawada, Andhra Pradesh 520008 Krishna ANDHRA PRADESH
9848134033
mohanarch@redifmail.com
Dr Mahesh Mangal
Sir Ganga Ram Hospital
Department of Plastic Surgery, Sir Ganga Ram Hospital, Rajinder Nagar-110060 New Delhi DELHI
9811049399
mc_mangal@hotmail.com
Dr Ashish Gupta
SPS Apollo Hospital
Department of Plastic & Microvascular Surgery, SPS Apollo Hospital, GT Road,
Dholewal, Ludhiana-161003, Punjab Ludhiana PUNJAB
09779771111
docashish2001@gmail.com
Dr Deepak Shankar Shetty
Sri Venkateswara Hospital
#86, Hosur Main Road, Madiwala, Bangalore- 560068, Karnataka Bangalore KARNATAKA
09880710945
deepak0472@yahoo.co.uk
Dr Abha Rani Kujur
St. Johns Medical College
Department of Plastic Surgery, St. Johns Medical College, Sarjapur Rd, Koramangala, Bengaluru, Karnataka 560034 Bangalore KARNATAKA
9980906422
dr_abha@rediffmail.com
Dr Shiv Prakash Singh
Sudbhawana Hospital Varanasi
B 31/80, 23 B-Bhogabir, Lanka, Varanasi-221005 Varanasi UTTAR PRADESH
09451224983
sudbhawanacrvns@gmail.com
Dr Smita S Segu
Victoria Hospital, Bangalore Medical College and Research Institute
1st Floor, Department of Plasic Surgery, Victoria Hospital, Bangalore Medical College and Research Institute, Fort, Bangalore-560002, Karnataka Bangalore KARNATAKA
09845192337
smithasegu@hotmail.com
Dr Sabrina M Pereria Vaz
Vintage Hospital and Medical Research Centre Pvt Ltd
Vintage Hospital and Medical Research Centre Pvt Ltd Panji 403001 Goa North Goa GOA
08326711414
cromgoa@gmail.com
Dr R P Narayan
VMMC & Safdarjung Hospital
Department of Plastic and Maxillofacial surgery, VMMC and Safdarjung Hospital, Ansari Nagar, New Delhi-110029 New Delhi DELHI
Thin layer of intervention [Silver Sulfadiazine cream (Nanonized) 0.5% w/w] sufficient to cover the burn wound(s) will be applied under aseptic conditions.
The cream will be applied topically once daily in case of closed dressings and twice daily in case of open dressings.
The requirement for closed or open dressings and its duration will be at the discretion of the investigator. The closed dressing will be carried out as per the practice of the clinic/hospital.
Treatment with the study medication will be continued until the wound heal or up to a period of 21 days, whichever is earlier.
Thin layer of comparator (Silverex cream 1% w/w) sufficient to cover the burn wound(s) will be applied under aseptic conditions.
The cream will be applied topically once daily in case of closed dressings and twice daily in case of open dressings.
The requirement for closed or open dressings and its duration will be at the discretion of the investigator. The closed dressing will be carried out as per the practice of the clinic/hospital.
Treatment with the study medication will be continued until the wound heal or up to a period of 21 days, whichever is earlier.
Inclusion Criteria
Age From
12.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Subjects of either sex aged between 12 and 65 years (both inclusive) and who have given written informed consent or assent to participate in the study. Additional written informed consent will be taken from parents or legally acceptable representative (LAR) [as applicable] in case assent is taken from subjects aged less than 18 yrs
2. Subjects with partial thickness burns of thermal origin covering 5-10% (both inclusive) of the total body surface area (TBSA) and suitable for outpatient management.
3. Subjects in whom burn injury is less than 24 hours old at the time of screening.
4. Subjects with clean, non-infected wound as judged by the investigator.
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) or perineum
5. Subjects with burns of hands or feet or major joints likely to cause functional impairment.
6. Subjects with burns and concomitant trauma (such as fractures) in which the burn injury poses the greatest risk of morbidity and mortality.
7. 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.
8. Subjects who are under treatment with topical or systemic steroid medications or immunosuppressive agents.
9. 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.
10. Subjects with history of glucose-6-phosphate dehydrogenase deficiency.
11. Subjects with history of substance abuse as per DSM IV criteria.
12. Pregnant or breast-feeding women or women of child-bearing potential not using medically acceptable methods of contraception or women with positive urine pregnancy test at screening.
13. Subjects who are unable or unwilling to comply with the study procedures.
14. Subjects who have participated in another investigational study within the last 1 month prior to entry in this study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
To compare the efficacy of Silver Sulfadiazine cream (Nanonized) 0.5% w/w with Silverex cream 1% w/w in the prophylaxis of infection in burn wounds
At the end of 7±2, 14±2 and 21±2 days
Secondary Outcome
Outcome
TimePoints
To compare the safety and tolerability of Silver Sulfadiazine cream (Nanonized) 0.5% w/w with Silverex cream 1% w/w in the prophylaxis of infection in burn wounds
At the end of 7±2, 14±2 and 21±2 days
Target Sample Size
Total Sample Size="250" Sample Size from India="250" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This study is a randomized, double-blind, comparative, parallel-group, multicentric Study, where treatment with the study medication will be continued until the wound heals or up to a period of 21 days, whichever is earlier. Subjects who achieve complete wound closure of all wounds before Day 21 will be considered to have completed the study as per protocol. In these subjects, further treatment with the study medication will be stopped. At the end of 21 days of treatment period, the study treatment will be discontinued. However, all subjects requiring further treatment of their burn wound will be treated as per the discretion of the investigator.
Study will be initiated only after obtaining regulatory approval & EC approval from respective sites.