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A clinical study on efficacy of maggot therapy for treatment of 3rd grade of burning ulcers

Protocol summary

Study aim
To evaluate the maggot therapy on 3rd burning ulcers on volunteer patients in Shahid Motahhari Hospital of Tehran
Design
A randomized design will conduct in this study. 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. After 6 time of categorizing the 24 cases will categorize as control or treatment group. Character A and B will allocate to control and treatment groups respectively.
Settings and conduct
This is a clinical trial study with 56 patients who will refer to Motahhari Hospital. Patients must sign an informed consent form before entering the study. Blinding will not be done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having at least one burning ulcer (3rd) with bacterial infection, lake of other sever disease such as heart, kidney or lung disorders, no need to use anticoagulants and or steroid pharmaceutics, no addiction with alcohol or opiums, no entomophobia Exclusion criteria: Appearing of sever diseases such as heart, kidney or lung disorders, having un-controlled fever, having sever pain and bleeding during treatment.
Intervention groups
Patients entered into the study will assign into two groups, control and intervention. Both groups will take routine treatments for burning ulcers and their related pharmaceutics. Routine therapy involves local and systemic measures, including surgery, debridement, various kinds of dressing, nutritional support, and antibiotic therapy. Patients in the intervention group, in addition to routine therapies, will receive maggot therapy as a method along with routine methods. Patients in the control group will be treated with routine methods only.
Main outcome variables
Reducing necrotic tissues and increasing of granulated tissues

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170531034272N2
Registration date: 2018-07-24, 1397/05/02
Registration timing: prospective

Last update: 2018-07-24, 1397/05/02
Update count: 0
Registration date
2018-07-24, 1397/05/02
Registrant information
Name
Javad Rafinejad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4293 3121
Email address
jrafinejad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical study on efficacy of maggot therapy for treatment of 3rd grade of burning ulcers
Public title
Efficacy of Maggot therapy on burning ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Tehran University of Medical Sciences
Street address
ٍEnghelab Street, Ghods Street
City
Tehran
Province
Tehran
Postal code
14155-6446
Approval date
2018-03-04, 1396/12/13
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4691

Health conditions studied

1

Description of health condition studied
Burning ulcers of grade 3
ICD-10 code
T21-25
ICD-10 code description
Burn and corrosion of trunk, shoulder and upper limb, wrist and hand, hip and lower limb, ankle and foot

Primary outcomes

1

Description
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

Secondary outcomes

1

Description
Bacterial infections, Staphilococcus aureus and Pseudomonas aeruginosa
Timepoint
48 and 96 hours after treatment
Method of measurement
culturing of samples in laboratory

Intervention groups

1

Description
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.
Category
Treatment - Surgery

2

Description
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.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mothhari Hospital of Tehran
Full name of responsible person
Mostafa Dah Mardei
Street address
Vali Asr Street, Rashid Yasemi Street
City
Tehran
Province
Tehran
Postal code
--
Phone
+98 21 8877 0031
Fax
Email
m.dahmardehei@gmail.com
Web page address
http://crtm.iums.ac.ir/fa?sid=49

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraiian
Street address
Enghelab Street, Ghods Street
City
Tehran
Province
Tehran
Postal code
14155-6446
Phone
+98 21 8163 3698
Fax
+98 21 8163 3686
Email
info@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Javad Rafinejad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Entomology
Street address
Enghelab Street, Ghods Street
City
Tehran
Province
Tehran
Postal code
14155-6446
Phone
+98 21 4293 3121
Fax
+98 21 8895 1393
Email
jrafinejad@tums.ac.ir
Web page address
https://www.tums.ac.ir/faculties/jrafinejad?lang=en&display=mysite

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kamran Akbarzadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Entomology
Street address
Department of Medical Entomology, School of Public Health, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3111
Fax
+98 21 8895 1393
Email
kakbarzadeh@tums.ac.ir
Web page address
https://www.tums.ac.ir/faculties/kakbarzadeh?lang=en&style=printfriendly

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Javad Rafinejad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Entomology
Street address
Department of Medical Entomology, School of Public Health, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14155-6446
Phone
+98 21 4293 3121
Fax
+98 21 8895 1393
Email
jrafinejad@tums.ac.ir
Web page address
https://www.tums.ac.ir/faculties/jrafinejad?lang=en&display=mysite

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data and documents about main outcome and secondary outcome
When the data will become available and for how long
starting 3 months after publication
To whom data/document is available
for all involving people
Under which criteria data/document could be used
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.
From where data/document is obtainable
- from website of Tehran University of Medical Sciences - from website of Shahid Motahhari Hospital of Tehran - from webpages of involved researchers
What processes are involved for a request to access data/document
- Sending email to kakbarzadeh@tums.ac.ir - Sending email to jrafinejad@tums.ac.ir
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