Comparison between absorption rate of Acelular Dermis and homograft Fascia Lata for prevention of dorsal irregularities in primary rhinoplasty patients
The aim of this study is to compare of Acellular Dermis and homograft Fascia Lata for nasal dorsal irregularities prevention. Inclusion criteria: the thin skin patients; 19 to 55 years old; with a dorsal nasal hump; without modification of radix.
Exclusion criteria: previous rhinoplasty surgery; history of nasal trauma and nasal fracture; diabetic mellitus; immunologic disease; vascular and hemorrhagic diseases. 68 patients with these inclusion and exclusion criteria for primary open rhinoplasty are enrolled. After a standard rhinoplasty procedure, a layer of Acellular Dermis with 0.6-0.9 mm thickness and 20 x 40 mm in dimension is placed in the pocket of the dorsum.
This study is performed in the private Markazi Clinic in Tehran from March 2013 and 2015. To assess the absorption rate of these two products as the primary outcome of the study, dorsal height is measured on right lateral photographs, 6 and 12 months after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014041717312N1
Registration date:2015-05-12, 1394/02/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-12, 1394/02/22
Registrant information
Name
Roghayeh Hamidian
Name of organization / entity
Rasul Akram Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 1011
Email address
armohebbi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kish Hamanandsazbaft Company
Expected recruitment start date
2013-03-04, 1391/12/14
Expected recruitment end date
2015-03-05, 1393/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between absorption rate of Acelular Dermis and homograft Fascia Lata for prevention of dorsal irregularities in primary rhinoplasty patients
Public title
Prevention of nasal skin irregularity after rhinoplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The thin skin patients; 19 to 55 years old; with a dorsal nasal hump; without modification of radix.
Exclusion criteria: previous rhinoplasty surgery; history of nasal trauma and nasal fracture; diabetic mellitus; immunologic disease; vascular and hemorrhagic diseases.
Age
From 19 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Ethics Committee, School of Medicine, Iran University of Medical Sciences, next to Milad Hospital, Hemat Highway
City
Tehran
Postal code
Approval date
2015-01-11, 1393/10/21
Ethics committee reference number
93/d/105/4844
Health conditions studied
1
Description of health condition studied
Follow-up care involving plastic surgery of open rhinoplasty
ICD-10 code
Z42.0
ICD-10 code description
Follow-up care involving plastic surgery of head and neck
Primary outcomes
1
Description
Acellular Dermis absorption rate
Timepoint
6 and 12 months after surgery
Method of measurement
Dorsal height is measured by using computer software Teb Negar Cosmetic Simusurge on right lateral photographs
2
Description
Homograft Fascia Lata absorption rate
Timepoint
6 and 12 months after surgery
Method of measurement
Dorsal height is measured by using computer software Teb Negar Cosmetic Simusurge on right lateral photographs
Secondary outcomes
1
Description
Infection
Timepoint
3 and 6 and 12 months after surgery
Method of measurement
Physical examination
2
Description
Dorsal irregularity
Timepoint
12 months after surgery
Method of measurement
Physical examination
3
Description
Migration of product
Timepoint
3 and 6 and 12 months after surgery
Method of measurement
Physical examination
4
Description
Extrusion of product
Timepoint
3 and 6 and 12 months after surgery
Method of measurement
Physical examination
5
Description
Seroma formation
Timepoint
3 and 6 and 12 months after surgery
Method of measurement
Physical examination
Intervention groups
1
Description
At the end of standard rhinoplasty procedure, a layer of Acellular Dermis with 0.6-0.9 mm thickness and 20 x 40 mm in dimension is placed in the pocket of the dorsum.
Category
Treatment - Surgery
2
Description
At the end of standard rhinoplasty procedure, a layer of homograft Fascia Lata with 0.9-0.6 mm thickness and 20 x 40 mm in dimension is placed in the pocket of the dorsum.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Markazi Clinic
Full name of responsible person
Dr Aliresa Mohebbi
Street address
No.29, Markazi Clinic, Valinejad Ave, Valiasr St
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kish Hamanandsazbaft Company
Full name of responsible person
Saba Hariri
Street address
No.8, Eastern 19th Ave, Sarafha St, Saadat Abad
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kish Hamanandsazbaft Company
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
Rasul Akram Hospital
Full name of responsible person
Dr Roghayeh Hamidian
Position
Resident of Otolaryngology Head and Neck surgery
Other areas of specialty/work
Street address
Department of Otolaryngology Head and Neck surgery, Rasul Akram Hospital, Niayesh Ave, Saterkhan St
City
Tehran
Postal code
Phone
+98 21 6651 1011
Fax
Email
hamidian.r@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasul Akram Hospital
Full name of responsible person
Dr Aliraza Mohebbi
Position
Assistant professor of Otolaryngology Head and Neck surgery
Other areas of specialty/work
Street address
Department of Otolaryngology Head and Neck surgery, Rasul Akram Hospital, Niayesh Ave, Sattarkhan St
City
Tehran
Postal code
Phone
+98 21 6651 1011
Fax
Email
mohebbidr@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rasul Akram Hospital
Full name of responsible person
Dr Roghayeh Hamidian
Position
Resident of Otolaryngology Head and Neck surgery
Other areas of specialty/work
Street address
Department of Otolaryngology Head and Neck surgery, Rasul Akram Hospital, Niayesh Ave, Satarkhan St
City
Tehran
Postal code
Phone
+98 21 6651 1011
Fax
Email
hamidian.r@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)