Objectives: Comparing Z-plasty versus Z-plasty and skin grafting in surgical tension free treatment of post-burn elbow contractures.
Design: Thirty patients with 15 to 60 degrees elbow joint extension restriction are going to participate in this study in two groups.
Setting and conduct: a hospital in Zanjan city, Iran, from March 2013.
Inclusion criteria: Having un-circumferential scar (circumferential until 75%); 15 to 60 degrees flexion and extension restriction in elbow joint; no joint ossification.
Exclusion criteria: having comorbid diseases; joint ossification; wound infection; underlying medical illnesses such as diabetes, uremia, hypertension, cardiovascular diseases, chronic arterial obstruction, immunodeficiency conditions and kidney failure; being younger than 15 or older than 60 years old; taking non-steroidal anti-inflammatory drugs; high dosage of corticosteroids or chemotherapy agents.
Intervention: In both groups Z-plasty is designed with a 60 degrees angle. But in the investigation group the flaps will be turned without tension. Then the upper and lower of the flaps will be grafted by mid split-thickness skin graft.
Outcome measures: The surgery area will be examined regarding infections, wound healing time, necrosis and scar. Significant differences will be evaluated using unpaired student T-test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201611235560N1
Registration date:2017-01-03, 1395/10/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-03, 1395/10/14
Registrant information
Name
Seyed Nejat Hosseini
Name of organization / entity
Zanjan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 24009833440300
Email address
nejat.hosini@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2016-12-19, 1395/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Z-plasty versus Z-plasty and skin grafting for surgical tension free treatment of post-burn elbow contractures: A randomized clinical trial
Public title
Comparing Z-plasty versus Z-plasty and skin grafting for surgical tension free treatment of post-burn elbow contractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having un-circumferential scar (circumferential until 75%); 15 to 60 degrees flexion and extension restriction in elbow joint; no joint ossification.
Exclusion criteria: having comorbid diseases; joint ossification; wound infection; underlying medical illnesses such as diabetes, uremia, hypertension, cardiovascular diseases, chronic arterial obstruction, immunodeficiency conditions and kidney failure; being younger than 15 or older than 60 years old; taking non-steroidal anti-inflammatory drugs; high dosage of corticosteroids or chemotherapy agents.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sealed envelope
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Zanjan University of Medical Sciences
Street address
Mahdavi Blvd
City
Zanjan
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
zums.rec.1392.118
Health conditions studied
1
Description of health condition studied
Elbow contracture
ICD-10 code
T22.0
ICD-10 code description
Burn of unspecified degree of shoulder and upper limb, except wrist and hand
Primary outcomes
1
Description
Infection
Timepoint
2nd, 4th, 8th, 12th, 24th weeks after the surgery
Method of measurement
Examination
2
Description
Wound healing time
Timepoint
2nd, 4th, 8th, 12th, 24th weeks after the surgery
Method of measurement
Examination
3
Description
Scar depth
Timepoint
2nd, 4th, 8th, 12th, 24th weeks after the surgery
Method of measurement
Examination
4
Description
Contracture details
Timepoint
2nd, 4th, 8th, 12th, 24th weeks after the surgery
Method of measurement
Examination
5
Description
Necrosis
Timepoint
2nd, 4th, 8th, 12th, 24th weeks after the surgery
Method of measurement
Examination
6
Description
New scar
Timepoint
2nd, 4th, 8th, 12th, 24th weeks after the surgery
Method of measurement
Examination
7
Description
Motion range of the joint
Timepoint
2nd, 4th, 8th, 12th, 24th weeks after the surgery
Method of measurement
Examination
Secondary outcomes
empty
Intervention groups
1
Description
The investigation group will be treated with Z-plasty and skin graft.
Category
Treatment - Surgery
2
Description
The control group will be treated with Z-plasty without skin graft.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Seyed Nejat Hosseini
Street address
Gavazang Blvd
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghli (vice chancellor for research)
Street address
Mahdavi Blvd
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Seyed Nejat Hosseini
Position
Plastic Surgeon and Academic Member
Other areas of specialty/work
Street address
Faculty of Medicine, Mahdavi Blvd
City
Zanjan
Postal code
4513956111
Phone
00
Fax
Email
nejat.hosini@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Seyed Nejat Hosseini
Position
Plastic and Aesthetic Surgery
Other areas of specialty/work
Street address
Faculty of Medicine, Mahdavi Blvd
City
Zanjan
Postal code
4513956111
Phone
+98 24 3344 0300
Fax
Email
nejat.hosini@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Seyed Nejat Hosseini
Position
Plastic and Aesthetic Surgery
Other areas of specialty/work
Street address
Faculty of Medicien, End of Mahdavi Blvd
City
Zanjan
Postal code
Phone
+98 24 3344 0300
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)