Treatment results of combined platelet-riched plasma and fat injection in patients with velopharyngeal insufficiency referral to Imam Khomeini Hospital between 2012-2013 years
Objectives: This study is aimed to evaluate treatment results of combined platelet-riched plasma and fat injection in patients with velopharyngeal insufficiency referral to Imam Khomeini Hospital between 2012-2013 years
Design: Prospective clinical trial.
Setting and conduct : Tertiary regional and teaching hospital.
Participants including major eligibility criteria: Patients with velopharyngeal insufficiency admitted in plastic surgery ward in Imam Khomeini Hospital between 2012-2013 years, were included.
Intervention: Combined injection of platelet-rich plasma (1 ml) and fat (4 ml) at the medial site of obstruction during velopharyngeal words are pronounced. Platelet-rich plasma was prepared from 10 ml of venous blood and fat of the abdomen was taken.
Main outcome measures (variables): Gap velopharyngeal ; Lateral displacement of the soft palate and the posterior pharyngeal wall motion analysis of video naso endoscopy; hypernasal resonance; Nasal air escape; Intelligibility.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306018435N5
Registration date:2013-06-10, 1392/03/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-10, 1392/03/20
Registrant information
Name
Seyed Masoud Hashemi
Name of organization / entity
Department of Anesthesiology and Pain
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 2252
Email address
mohammadinasab@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2012-08-10, 1391/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Treatment results of combined platelet-riched plasma and fat injection in patients with velopharyngeal insufficiency referral to Imam Khomeini Hospital between 2012-2013 years
Public title
Treatment results of combined platelet-rich plasma and fat injection in patients with velopharyngeal insufficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with repaired cleft palate; Patients aged 15-20 years;Patients with any defects in the pharyngeal wall area and volume;Patients undergoing injection of combined platelet-rich plasma and fat; Patients with mild to moderate velopharyngeal insufficiency confirmed by nasoendoscopy; signing consent to participate in the study.
Exclusion criteria: Neurological impairment ; Mental retardation; Tumor area velopharyngeal; Hearing loss; Presence of pharyngeal flap; Oronasal fistula;Large tonsils; Severe velopharyngeal insufficiency.
Age
From 15 years old to 20 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
15
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 Tehran University of Medical Sciences and Health Services
Street address
Poorsina Ave.
City
Tehran
Postal code
Approval date
2013-06-01, 1392/03/11
Ethics committee reference number
92/D/130/396
Health conditions studied
1
Description of health condition studied
Velopharyngeal insufficiency
ICD-10 code
M70.9
ICD-10 code description
Unspecified soft tissue disorder related to use, overuse and pressure
Primary outcomes
1
Description
Gap velopharyngeal
Timepoint
Before the injection, at 6 weeks and 6 months after the injection
Method of measurement
Nasal endoscopy video analysis
2
Description
Displacement of the soft palate
Timepoint
Before the injection, at 6 weeks and 6 months after the injection
Method of measurement
Nasal endoscopy video analysis
3
Description
Lateral and the posterior pharyngeal wall motion
Timepoint
Before the injection, at 6 weeks and 6 months after the injection
Method of measurement
Nasal endoscopy video analysis
4
Description
Hypernasal resonance
Timepoint
Before the injection, at 6 weeks and 6 months after the injection
Method of measurement
Repeat the words and phrases
5
Description
Nasal air escape
Timepoint
Before the injection, at 6 weeks and 6 months after the injection
Method of measurement
Repeat the words and phrases
6
Description
Intelligibility
Timepoint
Before the injection, at 6 weeks and 6 months after the injection
Method of measurement
Repeat the words and phrases
Secondary outcomes
empty
Intervention groups
1
Description
combined platelet-rich plasma and fat injection
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Hamid Reza Fathi
Street address
Gharib St., Keshavarz Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Shahin Akhunzadeh MD.
Street address
Poursina St.
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, Tehran University of Medical Sciences and Health Services
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
Imam Khomeini Hospital
Full name of responsible person
Hamid Reza Fathi
Position
Assistant Professor
Other areas of specialty/work
Street address
Gharib St., Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6643 8153
Fax
Email
hamifathi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Khomeini Hospital
Full name of responsible person
Hamid Reza Fathi
Position
Plastic and Reconstructive Surgeon
Other areas of specialty/work
Street address
Gharib St., Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6643 8153
Fax
Email
hamifathi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Khomeini Hospital
Full name of responsible person
Hamid Reza Fathi
Position
Assistant Professor
Other areas of specialty/work
Street address
Gharib St., Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6643 8153
Fax
Email
hamifathi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)