This study aimed to compare pulmonary air leak after surgery between patients that use fibrin glue at the end of surgery and those with routine method.
Design
Randomized, parallel groups, single blinded, phase 3 on 40 patients. The random permuted block design is used for randomization and for the concealment of permutations in order to reduce the predictability of randomization, the closed envelopes will be used..
Settings and conduct
The study will be done in Thoracic Surgery Department of Ghaem Hospital in Mashhad University of Medical Sciences.
In the intervention group, 50 cc's of blood will be taken from the patients two days before the surgery and about 5 cc's of autologous fibrin glue will be processed and sprayed on the damaged surfaces of the lung parenchyma in the final stage of the surgery . In the control group, surgery is performed routinely. Furthermore, the data analyst will also be unaware of the allocation of patients to groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients who are candidate for thoracic surgery
Exclusion criteria: Patients with sever comorbidity such as renal failure , cardio-pulmonary failure and liver failure
Intervention groups
In intervention group , the fibrin glue which is processed from the patient's own plasma is sprayed on the surface of lung parenchyma at the end of pulmonary surgery .In the control group, surgery is performed as usual.
Main outcome variables
The amount and duration of air leak from the test tubes
Chest tube drain
Pulmonary complications after surgery
The length of hospital stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190408043196N1
Registration date:2020-07-12, 1399/04/22
Registration timing:registered_while_recruiting
Last update:2020-07-12, 1399/04/22
Update count:0
Registration date
2020-07-12, 1399/04/22
Registrant information
Name
reza rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2840
Email address
rezaeir@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of autolog fibrin glue use on the improvment of air leak after thoracic surgery
Public title
Effect of fibrin glue use on the improvment of air leak
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidate for thoracic surgery will be included.
Exclusion criteria:
Patients who have a sever comorbidity such as renal failure , cardio-pulmonary failure and liver failure will be excluded from the study.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blocking as a method of restricted randomization that ensures the treatment groups are balanced at the end of every block will be used in this study.
Using Random Allocation Software, random permuted blocks of different sizes 4 or 6, each block containing an equal number of subjects from
each group, are designed and a unique identification code is assigned to each block. In this manner, after completion of a block, an equal number of subjects will be enrolled in each group. While referring to the doctor, one of the envelopes is randomly selected and according to the order of its contents, each patient is assigned to one of the groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst will not know which group is A or B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mashhad University of Medical Sciences
Street address
Thoracic surgery Department, Ghaem hospital, Ahmadabad street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.MUMS.REC.1397.324
Health conditions studied
1
Description of health condition studied
Turactomy and pulmonary resections or lung decoration (For empyema treatment)
ICD-10 code
J86
ICD-10 code description
Pyothorax
Primary outcomes
1
Description
Duration of air leak
Timepoint
After surgery on a daily basis during the hospital stay
Method of measurement
Duration of air leakage after surgery will be recorded during hospitalization.
Secondary outcomes
1
Description
length of hospital stay
Timepoint
After surgery on a daily basis during the hospital stay
Method of measurement
Counting the days of hospitalization of the patient from the day of surgery to discharge from the hospital
2
Description
Drainage of chest tube
Timepoint
After surgery on a daily basis during the hospital stay
Method of measurement
The drainage of chest tube after surgery is examined in the daily visit of patients during hospitalization.
3
Description
Postoperative pulmonary complications
Timepoint
during hospitalization and 7 and 30 days after surgery
Method of measurement
Postoperative pulmonary complications will be examined by a specialist during hospitalization and 7 and 30 days after surgery.
Intervention groups
1
Description
In the intervention group, 50 cc's of blood will be taken from the patients two days before the surgery and about 5 cc's of autologous fibrin glue will be processed and sprayed on the damaged surfaces of the lung parenchyma in the final stage of the surgery.
Category
Treatment - Other
2
Description
Control group: Surgery is performed routinely.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Reza Rezaei
Street address
Thoracic surgery unit, Qhaem hospital, Ahmadabad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3801 2840
Email
rezaeir@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreishi department , Daneshgah street , Mashhad , Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
tafaghodim@mums.ac.ir
Web page address
https://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Reza Rezaei
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Thoracic surgery unit, Ghaem hospital, Ahmadabad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3801 2840
Email
rezaeir@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Rezaei
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Thoracic surgery unit, Qhaem hospital, Ahmadabad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3801 2840
Email
rezaeir@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Rezaei
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Thoracic surgery unit, Ghaem hospital, Ahmadabad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 915 306 7052
Email
rezaeir@mums.ac.ir
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
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available