Comparison of the effect of topical tetracycline and placebo on the frequency of seroma formation after abdominoplasty
Design
Phase 2-3 randomized clinical trial with parallel groups which will be conducted on 100 patients undergoing abdominoplasty
Settings and conduct
This study will be conducted with the aim of comparison of the effect of topical tetracycline and placebo on the frequency of seroma formation after abdominoplasty on 100 patients attending Ali Ebne Abitaleb hospital in Zahedan city. After inclusion in the study, the patients will be assigned into two groups; tetracycline group and placebo group. In tetracycline group, powder of 10 tetracycline capsules is dissolved in 50 ml of normal saline and injected at the surgery site and in the placebo group 50 ml of normal saline is injected at the surgery site. 7 and 30 days after the surgery the patients are examined for seroma formation and the two groups will be compared together.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age of 35 to 55; body mass index of 30 to 40 kg/m2.
Exclusion criteria: having drug addiction; having underlying diseases such as cardiac, renal or liver diseases.
Intervention groups
Intervention group: powder of 10 tetracycline capsules is dissolved in 50 ml of normal saline and injected at the surgery site
Control group: 50 ml of normal saline is injected at the surgery site
Main outcome variables
Seroma formation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210224050489N1
Registration date:2021-04-03, 1400/01/14
Registration timing:registered_while_recruiting
Last update:2021-04-03, 1400/01/14
Update count:0
Registration date
2021-04-03, 1400/01/14
Registrant information
Name
Hamidreza Jami Mohareri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
mohareri@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-28, 1399/12/10
Expected recruitment end date
2021-04-04, 1400/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of topical tetracycline and placebo on the frequency of seroma formation after abdominoplasty
Public title
Comparison of the effect of topical tetracycline and placebo on the frequency of seroma formation after abdominoplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 35 to 55
Body mass index of 30 to 40 kg/m2
Exclusion criteria:
Having drug addiction
Having underlying diseases such as cardiac, renal or liver diseases
Age
From 35 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are randomly assigned into two groups (tetracycline and placebo) using a random number table. A random number table containing unrepeated numbers between 1 and 100 is selected and the reading is started from the left. If the number is odd the patient is assigned into tetracycline group and if the number is even the patient is assigned into placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and person evaluating the patients are not aware of patients assignment and so are blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Approval date
2020-11-29, 1399/09/09
Ethics committee reference number
IR.ZAUMS.REC.1399.505
Health conditions studied
1
Description of health condition studied
Abdominoplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Seroma formation
Timepoint
7 and 30 days after the surgery
Method of measurement
By inspecting the surgery site
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: powder of 10 tetracycline capsules is dissolved in 50 ml of normal saline and injected at the surgery site
Category
Prevention
2
Description
Control group: 50 ml of normal saline is injected at the surgery site
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abi Taleb Hospital
Full name of responsible person
Hamidreza Jami Mohareri
Street address
Khalije Fars Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
ayubabedi48@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5721
Email
Dr.Taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Hamidreza Jami Mohareri
Position
General surgery specialist
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Ali Ebne Abi Taleb Hospital ,Khalije Fars Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Fax
Email
mohareri@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hamidreza Jami Mohareri
Position
General surgery specialist
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Ali Ebne Abi Taleb Hospital ,Khalije Fars Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Fax
Email
mohareri@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hamidreza Jami Mohareri
Position
General surgery specialist
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Ali Ebne Abi Taleb Hospital ,Khalije Fars Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Fax
Email
mohareri@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available