The aim of this study is to determine the effect of Maggot therapy on burn wound debridement of grade 2 and 3. This study is a clinical trial of Phase I That on five volunteer patients with burns 2 and 3 with a wound surface below 25% and has an underlying medical condition, age or any other reason that surgery and anesthesia are contraindicated, is done. To intervene in this study is Srkata Lucilia larvae maggot therapy using the sterile technique in the laboratory with regard to the wound surface Bymartdad it is selected. According to the ulcer duration of maggot therapy between 3 to 14 days. Wound dressing daily until the wound to remove dead tissue (debridement) is replaced.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090629733N1
Registration date:2016-12-28, 1395/10/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-28, 1395/10/08
Registrant information
Name
Aliakbar Ataeikachouei
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 9995
Email address
ataeik-aa@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the Effects of Maggot Therapy on Burn Wound Debridement of Grade 2 and 3
Public title
Maggot Therapy of Burn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Informed Consent, Burn of less than 25%, Having Diseases, Old Age Or Any Other Reason That Surgery and Anesthesia is Contraindicated for Them.
Age
From 40 years old to 90 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz-Golestan Blvd-Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
61357-15794
Approval date
2016-08-13, 1395/05/23
Ethics committee reference number
IR.AJUMS.REC.1395.345
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T24-T25
ICD-10 code description
Burn and corrosion of hip and lower limb, except ankle and foot-Burn and corrosion of ankle and foot
Primary outcomes
1
Description
Debridement
Timepoint
every day
Method of measurement
visit
Secondary outcomes
empty
Intervention groups
1
Description
On average, 10 times per patient for 3 to 14 days using the Lucilia fly larvae, larval therapy is done
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Burn Taleghani Hospital Ahvaz
Full name of responsible person
Fatemeh Jahangiri Mehr
Street address
Burn Taleghani Hospital Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Behzad Sharif Makhmal Zadeh
Street address
Ahvaz-Golestan Blvd-Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Fatemeh Jahangiri Mehr
Position
MSc in Biostatistics
Other areas of specialty/work
Street address
Ahvaz-Golestan Blvd-Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3372 1522
Fax
Email
afsjm.90@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ali Akbar Ataei
Position
SubSpecialist of Plastic and Reconstructive Surgeon
Other areas of specialty/work
Street address
Burn Taleghani Hospital Ahvaz
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3333 2368
Fax
+98 61 3336 1544
Email
Ataeik-aa@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Fatemeh Jahangiri Mehr
Position
MSc in Biostatistics
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
61357-15794
Phone
00
Fax
Email
Afsjm.90@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)