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IRCT20170531034272N2 IRCT 2018-07-24 Tehran University of Medical Sciences Efficacy of Maggot therapy on burning ulcers A clinical study on efficacy of maggot therapy for treatment of 3rd grade of burning ulcers 2018-08-23 anticipated 24 Complete https://irct.ir/trial/31116 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A complete randomized design will conduct for categorizing of 24 of volunteer patients into two groups, control and treatment. Six possible arrangements of A and B will type on six cards including AABB, ABBA, BBAA, ABAB, BABA, BAAB. All cards will put in a box with shuffling. Dice will select a card for each time of categorizing. Each time of categorizing will appear the category of four patients to A (for control group) and B (for treatment group. Each card will return to box for next dicing. After 6 time of categorizing the 24 cases will categorize as control or treatment group. 3 Burning ulcers of grade 3. Intervention 1: Intervention group: Maggot therapy (use of larvae of Lucilia sericata) will use beside of routine therapeutic measures. Routine therapy may be involves local and systemic measures, various kinds of surgery, debridement, various kinds of dressing, nutritional support, and antibiotic and other pharmaceutic therapy. The number of larvae per wound in order to maggot therapy varies depending on the extent and depth of the wound and infection in different parts of the wound. A range of 8 to 10 larvae per cm2 of ulcer will use. Interventions will be done every 48 hours. Outcomes of the study (bacterial infections and extend of necrotic and granulated tissues) will be surveyed every 48 hours on the wounds. In this study, the duration of the intervention will be until complete remove of the necrotic tissue. Intervention 2: Control group: Patients of this group will receive routine therapy which may be involves local and systemic measures, various kinds of surgery, debridement, various kinds of dressing, nutritional support, and antibiotic and other pharmaceutic therapy. Outcomes of the study (bacterial infections and extend of necrotic and granulated tissues) will be surveyed every 48 hours on the wounds. In this study, the patients of control group will be under supervisions until complete remove of the necrotic tissue. Yes - There is a plan to make this available What will be shared: Data and documents about main outcome and secondary outcome When: starting 3 months after publication To whom: for all involving people Conditions: University teachers and researchers can request data via personal contact and they can use them for their lectures and teaching sessions. Using the data in advertisements and public broadcasting such as printed materials and so on should be arranged formally with Tehran University of Medical Sciences. Where to obtain: - from website of Tehran University of Medical Sciences - from website of Shahid Motahhari Hospital of Tehran - from webpages of involved researchers How to obtain: - Sending email to kakbarzadeh@tums.ac.ir - Sending email to jrafinejad@tums.ac.ir Comments:
public Javad Rafinejad
Enghelab Street, Ghods Street
Tehran Iran (Islamic Republic of) 14155-6446 +98 21 4293 3121 jrafinejad@tums.ac.ir Tehran University of Medical Sciences scientific Kamran Akbarzadeh
Department of Medical Entomology, School of Public Health, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1417613151 +98 21 4293 3111 kakbarzadeh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients who have at least one burning ulcer (3rd grade) with bacterial infection. Patients who have not need anticoagulant or steroid pharmaceutics. Patients who have not acute or other chronic diseases. Patients who have ُnot addicted to alcohol or opium. Patients who have not Osteomyelitis. Patients who have not entomophobia. no limit no limit Both Patients who have sever diseases such as heart disorders and so on during maggot Therapy. Patients who get sever and un-controlled fever during maggot therapy. Patients who have sever pain during maggot Therapy. Patients with maceration around the wound after each interval of maggot therapy. Patients who take bleeding during maggot therapy. T21-25 Burn and corrosion of trunk, shoulder and upper limb, wrist and hand, hip and lower limb, ankle and foot Treatment - Surgery Treatment - Surgery Intervention group: Maggot therapy (use of larvae of Lucilia sericata) will use beside of routine therapeutic measures. Routine therapy may be involves local and systemic measures, various kinds of surgery, debridement, various kinds of dressing, nutritional support, and antibiotic and other pharmaceutic therapy. The number of larvae per wound in order to maggot therapy varies depending on the extent and depth of the wound and infection in different parts of the wound. A range of 8 to 10 larvae per cm2 of ulcer will use. Interventions will be done every 48 hours. Outcomes of the study (bacterial infections and extend of necrotic and granulated tissues) will be surveyed every 48 hours on the wounds. In this study, the duration of the intervention will be until complete remove of the necrotic tissue. Control group: Patients of this group will receive routine therapy which may be involves local and systemic measures, various kinds of surgery, debridement, various kinds of dressing, nutritional support, and antibiotic and other pharmaceutic therapy. Outcomes of the study (bacterial infections and extend of necrotic and granulated tissues) will be surveyed every 48 hours on the wounds. In this study, the patients of control group will be under supervisions until complete remove of the necrotic tissue. Measuring the necrotic tissues. Timepoint: 48 and 96 hours after starting of treatment. Method of measurement: Photographing and measuring by MATLAB 1.6, the mathwork inc, natic, ma, 2000. Bacterial infections, Staphilococcus aureus and Pseudomonas aeruginosa. Timepoint: 48 and 96 hours after treatment. Method of measurement: culturing of samples in laboratory. Tehran University of Medical Sciences Approved 2018-03-04 Ethical Committee of Tehran University of Medical Sciences ٍEnghelab Street, Ghods Street Tehran Tehran Iran (Islamic Republic of)