| Scientific Title of Trial | A randomized clinical trial on management of wounds having biofilm using a desferrioxamine local application | |
| Public Title of Trial (in lay language) | To find the usefullness of Desferroxamine in healing of chronic woound | |
| Acronym, if any | None | |
| Brief title, if any | None | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
UTN: U1111-1119-9971 | |
| Disease or Health Condition(s) studied | Non healing chronic wounds | |
| 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 | |
| Study design | Methodology Study design A randomised controlled trial Study setting Surgery professorial wards of National Hospital of Sri Lanka Study population and study units Patients who are admitted to ward with chronic wounds of more than 3 months duration will be invited to take part in the research. All patients who consent to take part will be recruited and taken as a part of our study sample. One such patient will be a single study unit. |
|
| 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 |
|
| 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 | |
| Primary outcome(s) | Resolution of non healing chronic wounds | |
| Primary outcome(s) - time of assessment(s) | On day one, day 7 and day 14 | |
| Secondary outcome(s) | Identification of number and type of species by colony count | |
| Secondary outcome(s) - time of assessment(s) | On day one, day 7 and day 14 | |
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 16/05/2011 | |
| Anticipated end date | 16/05/2013 | |
| Recruitment status | Current | |
| State of ethics review approval | Ethical approval granted by Faculty of Medicine, University of Colombo Ethical Review Committee | |
| Funding source(s) | Improving Relevance and Quality of Undergraduate Education (IRQUE) Project | |
| Applicant's Email | trctrc1964@gmail.com | |
| Approval Status | Approved | |
| 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 |
|
| Primary Study Sponsor/ Organization | Dr Terrence Rohan Chinniah
Department of Microbiology, Faculty of Medicine, Kynsey Road, Colombo 2697513 trctrc1964@gmail.com |
|
| Contact Person for Public Queries | Dr T R Chinniah Consultant Microbiologist / Senior Lecturer Department of Microbiology, Faculty of Medicine, Kynsey Road, Colombo 0716094784 trctrc1964@gmail.com |
|
| Secondary Study Sponsor(s), (if any) | None |
|
