Home » Trials » SLCTR/2011/004
A randomized clinical trial on management of wounds having biofilm using a desferrioxamine local application
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SLCTR Registration Number
SLCTR/2011/004
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
A randomized clinical trial on management of wounds having biofilm using a desferrioxamine local application
Public Title of Trial
To find the usefullness of Desferroxamine in healing of chronic wounds
Disease or Health Condition(s) Studied
Non healing chronic wounds
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1119-9971
Any other number(s) assigned to the trial and issuing authority
EC/09/012 (Faculty of Medicine, University of Colombo Ethical Review Committee)
What is the research question being addressed?
Whether an iron chelator desferroxamine can be used to deprive the biofilm organisms of their iron requirements ? Hence making them susceptible to conventional management and curing of chronic wound
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
i. Clinicians and participants will be double blinded ii. Total 100 participants equally divided into 5 groups, each groups to have 10 control and 10 study participants iii. 5 doubling dilution desferrioxamine solutions ranging from 0.0625mg/ml to 1mg/ml will be made iv. Each study group to receive one of the above dilutions applied on the wounds for 1 week followed by routine wound treatment for 1 week, with 2 week routine treatment for control group v. Outcome will be assessed clinically using the University of Texas clasification and culturing of wound swabs/wound biopsies for species identification and colony counts vi. Routine treatment (eg: anti-diabetic treatment) will be initiated a maintained for all patients
Inclusion criteria
Inclusion criteria Patients who have chronic wound of more than 3 months duration
Exclusion criteria
Exclusion criteria i. Patients who do not give consent to take part and those who are not in a physical or mental state to give a valid informed consent ii. Patients below age 18 years iii. Patients who will be discharged without an in-ward care for the wound iv. Patients who get admitted for amputation which is the definitive mode of treatment for their wounds. Elimination criteria If any patient meets following criteria he/she will be eliminated from the study v. Patients who decide to withdraw their consent vi. Patients who will be discharged without a proper treatment for wound vii. Patients who leave against medical advice viii. Patients deceased during the hospital stay ix. Patients who will undergo amputation as the ultimate mode of treatment x. Patients who get allergies for the drugs
Primary outcome(s)
|
1.
Resolution of non healing chronic wounds |
[ On day one, day 7 and day 14 ] |
Secondary outcome(s)
|
1.
Identification of number and type of species by colony count |
[ On day one, day 7 and day 14 ] |
Target number/sample size
10 participants and 10 controls for each phases and it is planned for 5 phases . Hence the total number is 50 participants and 50 controls
Countries of recruitment
Sri Lanka
Anticipated start date
2011-05-16
Anticipated end date
2013-05-16
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
Improving Relevance and Quality of Undergraduate Education (IRQUE) Project
Regulatory approvals
Status
Approved
Date of Approval
2009-05-21
Approval number
EC/09/012
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr Terrence Rohan Chinniah
Consultant Microbiologist / Senior Lecturer
Department of Microbiology, Faculty of Medicine, Kynsey Road, Colombo
0716094784
trctrc1964@gmail.com
Contact Person for Public Queries
Dr Terrence Rohan Chinniah
Consultant Microbiologist / Senior Lecturer
Department of Microbiology, Faculty of Medicine, Kynsey Road, Colombo
0716094784
trctrc1964@gmail.com
Primary study sponsor/organization
Dr Terrence Rohan Chinniah
Department of Microbiology, Faculty of Medicine, Kynsey Road, Colombo
Department of Microbiology, Faculty of Medicine, Kynsey Road, Colombo
2697513
trctrc1964@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
