To find the usefullness of Desferroxamine in healing of chronic woound

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2011/004
• Date of registration: 22/03/2011
• Primary sponsor: Dr Terrence Rohan Chinniah
• Public title: To find the usefullness of Desferroxamine in healing of chronic woound
• Scientific title: A randomized clinical trial on management of wounds having biofilm using a desferrioxamine local application
• Date of first enrolment: 16/5/2011
• Target 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
• Recruitment status: Recruiting
• URL: http://www.slctr.lk/trial_details.asp?reg_id={589DB209-D149-448F-912D-E4499882DDE2}
• Study type: Interventional
• 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.

Countries of recruitment

Sri Lanka

Contacts

• Name: Dr T R Chinniah
• Affiliation: Consultant Microbiologist / Senior Lecturer

• Name: Dr Terrence Rohan Chinniah
• Affiliation: Consultant Microbiologist / Senior Lecturer

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Non healing chronic wounds

Intervention(s)

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

Primary Outcome(s)

Resolution of non healing chronic wounds

Secondary Outcome(s)

Identification of number and type of species by colony count

Secondary ID(s)

UTN: U1111-1119-9971

Source(s) of Monetary Support

Improving Relevance and Quality of Undergraduate Education (IRQUE) Project