Randomized clinical trial comparing surgical and aesthetic outcomes following endoscopic-assisted tissue neck expansion and open approach in reconstruction of major facial burn injuries
Objective: Recently endoscopy has shown promises in reconstructive surgeries using tissue expander placement. This study aims to compare outcomes between open and endoscopic-assisted neck tissue expander placement in reconstruction of post-burn facial scar deformity.
Design:Through a randomized clinical trial, patients with facial burn scar were assigned to either open group and endoscopic group undergoing placement of tissue expanders.
Setting and conduct: Department of Plastic and Reconstructive Surgery, Saint Fatima Hospital, Iran University of Medical Sciences, Tehran, Iran
Participants including major eligibility criteria: Patients with major facial burn injuries requiring tissue expansion reconstruction will be included. Patients with immnuocompromised status, extending burn to the neck region and inability to participate will be excluded.
Intervention: Tissue expanders are placed in neck through endoscopic approach in Intervention group and through open technique in Control group
main outcome measures variable: Complication rate, operative time, length of hospital stay and time to full expansion
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307319044N2
Registration date:2013-12-11, 1392/09/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-11, 1392/09/20
Registrant information
Name
Kamran Asadi
Name of organization / entity
Tehran University of Medical Sciences, Motahari Burn Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 6226
Email address
asadi_kamran@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-01-01, 1390/10/11
Expected recruitment end date
2013-10-01, 1392/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized clinical trial comparing surgical and aesthetic outcomes following endoscopic-assisted tissue neck expansion and open approach in reconstruction of major facial burn injuries
Public title
Reconstruction of major extensive facial burn injuries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Major facial burn injuries requiring tissue expansion reconstruction
Exclusion Criteria: Immnuocompromised status; extending burn to the neck region; inability to participate in the study
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethics Committee/ Iran University of Medical Sciences
Street address
Saint Fatemeh Hospital, Yousef Abad
City
Tehran
Postal code
1433933111
Approval date
2013-10-10, 1392/07/18
Ethics committee reference number
92-10-10-13509-478321
Health conditions studied
1
Description of health condition studied
Facial Burn
ICD-10 code
T20, T21,
ICD-10 code description
Burns and corrosions
Primary outcomes
1
Description
Operative time
Timepoint
During the Surgery
Method of measurement
Timer
2
Description
Hospital stay
Timepoint
During Hospitalization
Method of measurement
Calendar
3
Description
Time to Full Expansion
Timepoint
After the Surgery
Method of measurement
Calendar
Secondary outcomes
1
Description
Complications
Timepoint
Intra-operative and post-operative
Method of measurement
Examination and History Taking
Intervention groups
1
Description
Intervention group
Using an endoscopic approach, tissue expanders are placed in neck pocket tissue and connected to a port far away at the port site. Following achievement of full expansion of neck tissue, flaps are removed from expansion site and used for reconstruction of facial burn.
Category
Treatment - Surgery
2
Description
Control group
In this group, the traditional open approach is used to insert tissue expander and connected to the port near its location. After full expansion, tissues are removed and transferred to cover the facial burn scar deformities.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Plastic and Reconstructive Surgery/ Saint Fatima Hospital
Full name of responsible person
Kamran As'adi
Street address
Suite 2, Afra Tower, Khashayar Park, Africa Blvd
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr Morteza Nobakht
Street address
Hemmat Highway, Between Chamran and Sheikh Fazlollah, Iran University of Medical Sciences, Central Building, 5th Floor
City
Tehran
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, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Kamran As'adi
Position
Assistant Professor
Other areas of specialty/work
Street address
Suite 2, Afra Tower, Khashayar Park, Africa Blvd
City
Tehran
Postal code
1915683913
Phone
+98 21 8887 6226
Fax
Email
dr.kamran.asadi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kamran As'adi
Position
Assistant Professor
Other areas of specialty/work
Street address
Suite 2, Afra Tower, Khashayar Park, Africa Blvd
City
Tehran
Postal code
1915683913
Phone
+98 21 8887 6226
Fax
Email
dr.kamran.asadi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kamran As'adi
Position
Assistant Professor
Other areas of specialty/work
Street address
Suite 2, Afra Tower, Khashayar Park, Africa Blvd
City
Tehran
Postal code
1915683913
Phone
+98 21 8887 6226
Fax
Email
dr.kamran.asadi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)