Protocol summary
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Study aim
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Comparing the outcomes and complications of alar wedge excision and Serdev suturing techniques for alar base reduction surgery
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Design
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A randomized single-blind clinical trial study with a control group, with parallel design on 80 patients. Block randomization method will be used for randomization.
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Settings and conduct
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Khalili and Ghadir Mother and Child hospital affiliated to Shiraz University of Medical Sciences
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age> 18 years, patients with primary surgery, absence of systemic and dermatologic diseases.
Exclusion criteria: if patients did not returned follow-up visit after 12 months or had previous scar in site of alarplasty with any reasons.
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Intervention groups
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First group: patients who underwent Serdev suturing technique.
Second group: patients who underwent alar wedge excision technique.
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Main outcome variables
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Duration of procedure; amount of bleeding; need for bleeding control
General information
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Reason for update
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Primary and secondary outcomes were entered instead of each other that corrected. Also, the study is single-blind because the patients were not blind.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20131020015083N2
Registration date:
2021-11-20, 1400/08/29
Registration timing:
retrospective
Last update:
2022-02-05, 1400/11/16
Update count:
1
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Registration date
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2021-11-20, 1400/08/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-05-21, 1399/03/01
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Expected recruitment end date
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2021-09-22, 1400/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the outcomes and complications of alar wedge excision and Serdev suturing techniques for alar base reduction surgery
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Public title
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Comparing of alar wedge excision and Serdev suturing techniques for alar base reduction surgery
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age> 18 years
Patients with primary surgery
Absence of systemic and dermatologic diseases
Exclusion criteria:
Previous scar in the site of alarplasty
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants were randomly assigned to Serdev (number 0 in select case) or external wedge resection (number 1 in select case) groups (1: 1 ratio) using random numbers which were generated through computerized block randomization using SPSS software version 23. To reduce selection bias and confounding factors, randomization was performed by a single appointed researcher who did not participate in data collection.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Outcome assessor, Investigator and statisticians who analyzed the data were unaware of the intervention and allocation of treatments until the statistical analysis was complete.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-05-06, 1399/02/17
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Ethics committee reference number
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IR.SUMS.MED.REC.1399.064
Health conditions studied
1
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Description of health condition studied
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patients with large alar base
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ICD-10 code
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Z41.1
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ICD-10 code description
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Encounter for cosmetic surgery
Primary outcomes
1
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Description
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Scar formation
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Timepoint
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12 months after surgery
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Method of measurement
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Direct examination
2
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Description
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Satisfaction score
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Timepoint
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12 months after surgery
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Method of measurement
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ROE and PSAQ questionnaire
Secondary outcomes
1
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Description
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Amount of bleeding
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Timepoint
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Intra-operative
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Method of measurement
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Volume of bleeding (CC)
2
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Description
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Duration of procedure
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Timepoint
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Intra-operative
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Method of measurement
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Digital chronometer (sec)
3
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Description
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Need for bleeding control
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Timepoint
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Intra-operative
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Method of measurement
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Using electrocautery to stop bleeding
Intervention groups
1
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Description
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Intervention group: Serdev suturing technique
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Category
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Treatment - Surgery
2
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Description
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Control group: External wedge resection
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Category
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Treatment - Surgery
1
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Sponsor
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Grant name
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Grant code / Reference number
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98-01-01-21228
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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all collected deidentified IPD
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When the data will become available and for how long
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starting 6 months after publication
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To whom data/document is available
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only available for people working in academic institutions.
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Under which criteria data/document could be used
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there is no specified criteria
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From where data/document is obtainable
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corresponding author (09177395073, babaei@sums.ac.ir)
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What processes are involved for a request to access data/document
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the request should be sent by email (containing personal and professional information), describing their study protocol, after approving their identity and proposal, the data will be sent by email.
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Comments
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