Investigating the effectiveness of intranasal PRF treatment compared to standard treatment on mucosal healing at the cautery site during rhinosinusitis endoscopic surgery in chronic rhinosinusitis patients referred to Taleghani Hospital during 1403-1405
Determining and comparing the effectiveness of intranasal platelet-rich fibrin (PRF) treatment with standard treatment on mucosal healing at the cautery site during FESS surgery in chronic sinusitis patients
Design
The method of randomizing the nasal cavity of the patients in two groups will be block.
There are 61 people in this study
Settings and conduct
during FESS surgery in chronic rhinosinusitis patients referred to Taleghani Hospital during 1403-1405
Participants/Inclusion and exclusion criteria
Age between 18 and 60 years, bilateral chronic rhinosinusitis with nasal polyps, and difference in scores of two or less
LUND MACKY SCORE between both nostrils. Patients with unilateral nasal polyps, enterocean polyps, chronic rhinosinusitis without polyps, a history of nasal or sinus surgery, and chronic disorders and immunodeficiencies that impair wound healing will not be included in this study.
Intervention groups
In this study, all adult patients over 18 years of age suffering from chronic rhinosinusitis undergoing FESS surgery who referred to Taleghani Hospital from 1403 to 1405 will be examined. In this study, patients for whom electrocautery is used in two nasal cavities during FESS surgery, platelet-rich fibrin (PRF) is prepared using the patient's own venous blood, and randomly placed in one of the nasal cavities at the cautery site. is given and the other cavity of the nose is repaired in a standard way, and this cavity is considered as the control group. Then both cavities under the endoscopic guide are homeostasised and packed in the same way. The cautery device is the same for all patients and the intensity is 20 degrees and bipolar cautery is used.
Main outcome variables
Helping to treat early mucosal destruction and reduce the recurrence of the disease
General information
Reason for update
Acronym
PRF
IRCT registration information
IRCT registration number:IRCT20240518061832N1
Registration date:2024-10-17, 1403/07/26
Registration timing:registered_while_recruiting
Last update:2024-10-17, 1403/07/26
Update count:0
Registration date
2024-10-17, 1403/07/26
Registrant information
Name
vahid Ghasem amooeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 991 915 3531
Email address
vahidvm2m@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-06, 1403/07/15
Expected recruitment end date
2026-10-07, 1405/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of intranasal PRF treatment compared to standard treatment on mucosal healing at the cautery site during rhinosinusitis endoscopic surgery in chronic rhinosinusitis patients referred to Taleghani Hospital during 1403-1405
Public title
Investigating the effectiveness of intranasal PRF treatment compared to standard treatment on mucosal healing at the cautery site during rhinosinusitis endoscopic surgery in chronic rhinosinusitis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Bilateral chronic rhinosinusitis with nasal polyps
A difference in scores of two or less LUND MACKY SCORE between both nasal cavities
Age between 18 and 60 years
Exclusion criteria:
Patients with unilateral nasal polyps
antrochoanal polyp
Chronic rhinosinusitis without polyps
History of nose or sinus surgery
Immunity deficiency
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:
61
Randomization (investigator's opinion)
Randomized
Randomization description
For simple randomization, the number table of Rand company's program is used, and a plan is given for intervention in each of the donor nasal cavities by the operator, and one of the cavities is randomly selected as the intervention group, and fibrin rich in platelets is included in it. The hole is placed. Also, the other hole is determined as a sample and control group. All this information is recorded by the project manager, and in order not to affect the surgical procedure, the surgeon is not informed until the end of the operation.
Determining and comparing the effectiveness of intranasal platelet-rich fibrin (PRF) treatment with standard treatment on wound healing at the cautery site during FESS surgery in chronic sinusitis patients
Timepoint
Patients 3 days after surgery and after removing tampons if any and two weeks after surgery and one month after surgery and three months after surgery in terms of shortness of breath and bleeding and endoscopic findings in terms of adhesion and wound healing and site Wounds and cautery are checked.
Method of measurement
Accordingly, the following were scored by endoscopic assessment: Adhesion (0 = none, 1 = adhesion not affecting sinus drainage, 2 = moderate adhesion affecting sinus drainage, 3 = complete adhesion between the middle and lateral prongs of the nasal wall (bleeding) 0 = none; 1 = minimal, confined to nasal cavity; 3 = severe, need for cauterization (0 = minimal, 2 = moderate, 3 = severe) (0) = no infection, 1 = mild purulent mucous discharge, 2 = moderate purulent mucous discharge, 3 = severe purulent mucous discharge) granulation (0 = none, 1 = minimal, 2 = moderate, 3 = severe) also from patient questionnaire NOSE and history are taken before and after surgery and during the follow-up period. Finally, all the information is collected and then the statistical analysis of the data is done.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, all adult patients over 18 years of age suffering from chronic rhinosinusitis undergoing FESS surgery who referred to Taleghani Hospital from 1403 to 1405 will be examined. In this study, patients for whom electrocautery is used in two nasal cavities during FESS surgery, platelet-rich fibrin (PRF) is prepared using the patient's own venous blood, and randomly placed in one of the nasal cavities at the cautery site.
Category
Treatment - Surgery
2
Description
Control group: After one of the patient's nasal cavities was randomly selected for intervention. The other cavity of the nose is repaired in a standard way, and this cavity is considered as the control group. Then both cavities under the endoscopic guide are homeostasised and packed in the same way. With this method, the control group and the intervention are performed on one patient, which creates a better matching for this plan.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
patients referred to Taleghani Hospital during 1403-1405