(1) Objectives: Evaluate the efficacy of Low Level laser therapy after Split thickness skin graft in type 2-3 burn ulcers.
(2) Design: The study population is patients with type 2 or 3 burn ulcers admitted to Motahari hospital and have at least two symmetric ulcers in their body, one ulcer will include in intervention group and the other will use as control randomly by dropping coin. At least five patients will be recruited and the trial will be conducted as triple blind, phase three, mono centric trial.
(3) Setting and conduct: Skin graft surgery will be applied for both ulcers and then laser therapy will be applied for the ulcer which has been randomly selected for intervention group. Ultimately Intervention and control ulcers will be compared regarding ulcer size and side effect of surgery.
(4) Participants: Patients with type 2 or 3 burn ulcers without systematic diseases or photosensitization.
(5) Intervention: Low level laser therapy after skin graft.
(6) Main outcome measures: Wound healing, Hypertrophic scar, rate of wound healing, wound dehiscence
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016020226069N2
Registration date:2016-02-15, 1394/11/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-15, 1394/11/26
Registrant information
Name
Fereshteh Ansari
Name of organization / entity
Razi Vaccine and Serum Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 26 3405 0400
Email address
ansarif@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Laser Application in Medical Sciences Research Center, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-02-08, 1394/11/19
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Application of Low level Laser Therapy After Split Thickness Skin Graft in Grade 2-3 Burn Ulcers
Public title
Application of Low level Laser Therapy After Skin Graft in Burn Ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with symmetric type 2 or 3 burn ulcers
Exclusion criteria: bleeding tendency; presences of gangrene; renal failure; systemic disease; pregnancy; epilepsy; photosensivity
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
5
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical science, Next to Ayatollah Taleghani Hospital ,Evin , Tehran, Iran
City
Tehran
Postal code
198396-3113
Approval date
2015-11-28, 1394/09/07
Ethics committee reference number
IR.SBMU.RAM.REC.13940.363
Health conditions studied
1
Description of health condition studied
Degree two or three burn ulcer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Wound size
Timepoint
End of first and second week after treatment
Method of measurement
Pictzar software
Secondary outcomes
1
Description
Hypertrophic scar
Timepoint
By the end of first, second, third and sixth month after treatment onset
Method of measurement
Vancuver scar scale
2
Description
Rate of healing
Timepoint
The end of first and second week after treatment onset
Method of measurement
Examination
3
Description
Wound dehiscence
Timepoint
The end of first and second week after treatment onset
Method of measurement
Examination
Intervention groups
1
Description
Intervention group: Skin graft and Low level laser therapy
Category
Treatment - Other
2
Description
Control group: Skin graft
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Hospital
Full name of responsible person
Noshafarin Kazemikhoo
Street address
hahid Motahari treatment center, Rashid Yasemi street, Valiasr street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Laser application in medical science research centre
Full name of responsible person
Dr Parvin Mansouri
Street address
Shohada Tajrish Hospital, Laser application in medical sciences research center
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Laser application in medical science research centre
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
Skin and Stem Cell Research Center
Full name of responsible person
Nooshafarin Kazemikhoo
Position
PhD
Other areas of specialty/work
Street address
No;4, Maryam alley, the southern Kamranyeh street.
City
Tehran
Postal code
Phone
+98 21 2227 8950
Fax
Email
nooshakazemi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin and Stem Cell Research Center
Full name of responsible person
Nooshafarin Kazemikhoo
Position
PhD
Other areas of specialty/work
Street address
No;4, Maryam alley, the southern Kamranyeh street.
City
Tehran
Postal code
Phone
+98 21 2221 2537
Fax
Email
nooshakazemi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Skin and Stem Cell Research Center
Full name of responsible person
Fereshteh Ansari
Position
PhD student of epidemiology
Other areas of specialty/work
Street address
No;4, Maryam alley, the southern Kamranyeh street.
City
Tehran
Postal code
Phone
+98 21 2221 2537
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)