the effect of amniotic membrane on the success of nasal septal perforation surgery
Design
clinical trial with 12 patients without control group
Settings and conduct
12 patients with symptomatic nasal septum perforation who refer to oral and maxillofacial clinic of
Imam reza hospital of Tabriz, will be operated. After hemitransfixion incision, a mucoperichondreal flap will be elevated. In the other side, mucosal rotational flap based on posterior nasal artery will be elevated and suture to perforation borders. Five folded amniotic membrane will be located in mucoperichondreal pocket as an interpositional graft and suture. Patients will be evaluated for perforation closure on one and six month after surgery.
Participants/Inclusion and exclusion criteria
this study will include patients who give informed consent and are ASA I or ASA II and have 2 cm or less nasal septal perforation. we will exclude smokers and drug abusers.
Intervention groups
12 patients with symptomatic nasal septum perforation will be operated. After hemitransfixion incision,
a mucoperichondreal flap will be elevated. In the other side, mucosal rotational flap based on posterior nasal artery will be elevated and sutured to the perforation borders. Five folded amniotic membrane will be located in mucoperichondreal pocket as an interpositional graft and sutured. Patients will be evaluated for perforation closure on one and six month after surgery.
Main outcome variables
perforation existence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190513043578N1
Registration date:2019-07-30, 1398/05/08
Registration timing:registered_while_recruiting
Last update:2019-07-30, 1398/05/08
Update count:0
Registration date
2019-07-30, 1398/05/08
Registrant information
Name
Mohsen Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
mohsen.hashemi3263@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Surgical management of nasal septal perforation by mucosal flap rotation and amniotic membrane graft
Public title
Surgical management of nasal septal perforation by mucosal flap rotation and amniotic membrane graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients who give informed consent
patients with nasal septum perforation that is 2 cm or less in large diameter
ASA I (healthy) and ASA II ( with minor systemic disease) patients
Exclusion criteria:
smoker patients
drug abuser patients
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht Ave. Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-11-21, 1397/08/30
Ethics committee reference number
IR.TBZMED.REC.1397.662
Health conditions studied
1
Description of health condition studied
nasal septum perforation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
perforation existence
Timepoint
before surgery and one month after surgery
Method of measurement
inspection
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After general anesthesia and oral intubation, lidocaine 2% with epinephrine 1 100,000 will be injected in septal area . Then, using the hemitransfixion incision, the mocoperichondrial flap will be raised and the edges of the perforation will be cut off with a blade. Before elevating the flap, an aluminum suture envelope will be placed to support the mucoperichondrial flap. Then on the opposite side, the cut from the posterior and lower parts of the septum will begin to elevate mucusal flap, and will continue to the anterior and upper to reach the anterior margin of the perforation. This flap is based on the posterior nasal artery, which is a branch of the sphenopalatine artery.In some cases, releasing the posterior side of the flap will increase the radius of rotation. This flap will cover the edges of the perforation. Amniotic membrane will be provided from the cesarean section of the volunteer patients . This membrane is first completely washed with normal saline and stored in normal saline and one gram cephalexin in the refrigerator at 4 ° C. The amniotic membrane in five layers as an Interpositional graft will be placed in the mucoperichonrial pocket .sutures will be used to fix the membrane and prevent the formation of hematoma. the nose packed for three days.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
oral and maxillofacial clinic of Emam Reza hospital of Tabriz
Full name of responsible person
Mohsen Hashemi
Street address
Golgasht Ave. Emam Reza hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 7054
Fax
+98 41 3335 2073
Email
informo@imamreza.tbzmed.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Juiban
Street address
Tabriz university of medical sciences, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohsen Hashemi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tabriz university of medical sciences, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3333 8046
Email
mohsen.hashemi3263@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohsen hashemi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tabriz university of medical sciences, Golgasht Ave.
City
tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3333 8046
Email
mohsen.hashemi3263@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohsen Hashemi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tabriz university of medical sciences, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3333 8046
Email
mohsen.hashemi3263@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD