Objectives:
We want to introduce an alternative and less invasive method in management of hypertrophic burn scar.
Design:
Double-blinded randomized clinical trial
Method:
In this double-blinded randomized clinical trial, 56 patients with hypertrophic burn scar due to burn injury based on following criteria will allocate randomly to Dexamethasone and control group(each group 28 individual). Patients in both group will have routine burn scar therapy but individuals in intervention group will receive 10 sessions of Dexamethasone 0.4% phonophoresis (3 sessions/ wk) and individuals in control group will have placebo phonophoresis (ultrasound with normal routine aquatic gel without any Dexamethasone) with the same protocol. Phonophoresis sessions will be accomplished by our physiotherapist . Base line and follow-up visits will be done by one of our authors. Both the physiotherapist and our physiatrist who visits patients are blinded to group randomization. Hypertrophic scar characteristics and pruritus will be measured by “Vancouver Scar Scale(VSS)”, and “5-D Pruritus Scale” respectively in both groups. In the last session of treatment program and one week after, same measurements will be done. Pain perceived during phonophoresis subjectively will be recorded by “Visual Analog Scale” in both group in every session of phonophoresis therapy.
Participants:
Inclusion criteria: age between 18-65 years old; at least 8 weeks post injury; scar size below 25 cm square
Exclusion criteria: Diabetes mellitus; clinical anemia ; peripheral vascular disease; hypotension; congestive heart failure; immunodeficiency; chemotherapy; malignancy; lactation; pregnancy; near brain, eye and reproductive organ
Intervention:
We use pulsed ultrasound with 1-1.5 watt per centimiter square intensity and 1 mega hertz frequency for maximum 7 minutes in each session. We use Dexamethasone 0.4% gel and common aquatic ultrasound gel in intervention and control group respectively.
Primary outcome:
Hypertrophic scar characteristics
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407184104N4
Registration date:2015-04-06, 1394/01/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-06, 1394/01/17
Registrant information
Name
Mohammad Rahbar
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1544 6694
Email address
rahbarm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research, Tabriz medical science university
Expected recruitment start date
2015-03-10, 1393/12/19
Expected recruitment end date
2015-09-11, 1394/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Dexamethasone phonophoresis versus placebo efficacy on burn hypertrophic scar characteristics
Public title
Hypertrophic burn scar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18-65 years old; at least 8 weeks post injury; scar size below 25 cm square
Exclusion criteria: Diabetes mellitus; clinical anemia ; peripheral vascular disease; hypotension; congestive heart failure; immunodeficiency; chemotherapy; malignancy; lactation; pregnancy; near brain, eye and reproductive organ
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz Medical Science University Ethics Committie
Street address
3rd floor, Central building number 2, Tabriz medical science university, Golgasht St
City
Tabriz
Postal code
Approval date
2015-02-23, 1393/12/04
Ethics committee reference number
93178
Health conditions studied
1
Description of health condition studied
Hypertrophic burn scar
ICD-10 code
L91.0
ICD-10 code description
Hypertrophic scar
Primary outcomes
1
Description
Hypertrophic Scar Characteristics
Timepoint
begining, last session and one week after intervention
Method of measurement
Vancouver Scar Scale
Secondary outcomes
1
Description
Scar pruritus
Timepoint
begining, last session and one week after intervention
Method of measurement
5-D Pruritus Scale
Intervention groups
1
Description
Intervention group: Dexamethasone 0.4 % gel phonophoresis for maximum 7 minutes in each session for total 10 session by pulsed ultrasound with 1-1.5 watt per centimiter square intensity and 1Mega Hertz frequency
Category
Rehabilitation
2
Description
Control group: Common aquatic gel phonophoresis for maximum 7 minutes in each session for total 10 session by pulsed ultrasound with 1-1.5 watt per centimiter square intensity and 1 mega hertz frequency
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical medicine and rehabilitation research center
Full name of responsible person
Dr. Mohammad Rahbar
Street address
Physical medicine and rehabilitation ward, Imam Reza hospital, Golgasht St.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research, Tabriz Medical Science University
Full name of responsible person
Dr. Mohammadreza Rashidi
Street address
3rd floor, Central building number 2, Tabriz Medical Science University, Golgasht St.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research, Tabriz Medical Science University
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
Physical medicine and rehabilitation group, Tabriz medical science university
Full name of responsible person
Alireza Pishgahi
Position
Resident
Other areas of specialty/work
Street address
Physical medicine and rehabilitation ward, Imamreza hospital, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 3336 1928
Fax
Email
ar_pishgahi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz medical science university
Full name of responsible person
Mohammad Rahbar
Position
Physical medicine and rehabilitation Assistant Professor
Other areas of specialty/work
Street address
Physical medicine and rehabilitation ward, Imamreza hospital, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 3336 1928
Fax
Email
rahbarm@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Physical medicine and rehabilitation group
Full name of responsible person
Alireza Pishgahi
Position
Resident
Other areas of specialty/work
Street address
Physical medicine an rehabilitation ward, Imamreza hodpital, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 3337 3967
Fax
Email
ar_pishgahi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)